The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19

Shots:

  • Roche confirms that the US govt. will purchase additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed
  • The agreement additional supply of Regeneron’s Ab cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed.
  • The cocktail has received the US FDA’s EUA for recently diagnosed, high-risk, mild to moderate COVID-19 patients. Roche & Regeneron collaborated to develop and manufacture casirivimab and imdevimab under which Regeneron is distributing it in the US while Roche will be responsible for distribution outside the US

Click here ­to­ read full press release/ article | Ref: Roche | Image: Bloomberg

The post The US Government to Purchase Additional Doses of Regeneron’s Casirivimab and Imdevimab to Combat COVID-19 first appeared on PharmaShots.

PharmaShots Weekly Snapshots (Dec 28- 31, 2020)

Sinopharm’s COVID-19 Vaccine Demonstrates 79% Efficacy in P-III Study

Published: Dec 30, 2020 | Tags: COVID-19, Interim Analysis, New Coronavirus Inactivated Vaccine, P-lll Study, reports, results, Sinopharm

Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Published: Dec 28, 2020 | Tags: CysticFibrosis, Drug, New, reports, Submission, Treatment, Trikafta, Vertex

The US FDA Grants EUA for Quanterix’s Simoa Semi-Quantitative SARS-CoV-2 IgG Antibody Test

Published: Dec 29, 2020 | Tags: Emergency Use Authorization, Grants, Quanterix’s Simoa, Semi-Quantitative SARS-CoV-2 IgG Antibody Test, Us FDA

Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

Published: Dec 30, 2020 | Tags: COFEPRIS, Marketing Authorization Application, reports, Sorrento, Submission

Health Canada Accelerates the Review for AstraZeneca’s COVID-19 Vaccine

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, COVID-19, Health Canada, reports, Statement, UK, vaccine

Incyte Collaborates with Cellenkos for CK0804 to Treat Myelofibrosis

Published: Dec 30, 2020 | Tags: Cellenkos, CK0804, Development, Global, Incyte, License Agreement, Myelofibrosis, Signs

Zydus Cadila Seeks Approval to Commence P-III Clinical Study of ZyCoV-D

Published: Dec 24, 2020 | Tags: Clinical, Data, Nod, P-I/II, P-III, Seeks, Start, Submits, Trial, Trials, ZyCoV-D, Zydus Cadila

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Published: Dec 29, 2020 | Tags: antibody, Cocktail, COVID-19, Data, Encouraging, flow, Hospitalized, Initial, Low, Oxygen, patients, Regeneron, reports, Trial

AstraZeneca’s AZD1222 Receives MHRA’s Emergency Supply Authorization in the UK

Published: Dec 30, 2020 | Tags: AstraZeneca, Authorization, AZD1222, Emergency, MHRA, receives, Supply, UK

Skyhawk Collaborates with Vertex to Discover and Develop Novel Small Molecules Modulating RNA Splicing for Serious Diseases

Published: Dec 22, 2020 | Tags: Develop, Discover, License Agreement, Novel Small Molecules for Serious Diseases, Sign, Skyhawk, Strategic Research, Vertex

Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

Published: Dec 29, 2020 | Tags: EMA, Label Extension, Novo Nordisk, reports, Semaglutide, Submission, T2D

Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Published: Dec 28, 2020 | Tags: Advanced, Chi-Med, Initiates, NDA, Neuroendocrine, Rolling, Submission, Surufatinib, Treat, Tumors, Us FDA

Alligator Bioscience Submits CTA for the P-II OPTIMIZE-1 Study of Mitazalimab

Published: Dec 28, 2020 | Tags: Alligator Bioscience, CTA, Mitazalimab, OPTIMIZE-1, P-II, study, Submits

Pfizer Report the US FDA’s Acceptance and Priority Review of sNDA for Lorbrena (lorlatinib) to treat (ALK)-Positive (NSCLC)

Published: Dec 28, 2020 | Tags: Acceptance, Lorbrena (lorlatinib), Pfizer, Priority Review, Report, sNDA, treat (ALK)-Positive (NSCLC), US FDA’s

Biocon has Launched Tacrolimus Capsules in the US

Published: Dec 28, 2020 | Tags: Biocon, Launches, Tacrolimus Capsules, US

Myovant Signs Agreement with Pfizer to Develop and Commercialize Relugolix in Oncology and Women’s Health

Published: Dec 28, 2020 | Tags: Agreement, Commercialize, Develop, health, Myovant, Oncology, Pfizer, Relugolix, Signs, Women

Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Published: Dec 28, 2020 | Tags: Amivantamab, EGFR Exon 20 Insertion Mutations, EMA, Janssen, MAA, Metastatic Non-Small Cell Lung Cancer, Report, Submission

Zai Lab Signs an Exclusive License Agreement with Cullinan Oncology for the Development and Commercialization of CLN-081 in Greater China

Published: Dec 28, 2020 | Tags: CLN-081, Commercialization, Cullinan Oncology, Development, Exclusive License Agreement, Greater China, Signs, Zai Lab

Algernon’s Last Patient Out in NP-120 (Ifenprodil) P-IIb/III Study for COVID-19

Published: Dec 24, 2020 | Tags: Algernon, COVID-19, Ifenprodil, Last Patient Out, Multinational, P-IIb, P-IIb/III, reports

Casi and Juventas Cell Therapy’s CNCT19 (CD19 CAR-T) Receives China NMPA’s BT Designation for Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Published: Dec 24, 2020 | Tags: (CD19 CAR-T), Breakthrough Therapy Designation, BT Designation, Casi, CNCT19, NMPA, receives, Relapsed/refractory B-Cell Acute Lymphoblastic Leukemia (B-ALL)

Amyrt’s AP103 Receives the US FDA’s Orphan Drug designation for Dystrophic Epidermolysis Bullosa (DEB)

Published: Dec 23, 2020 | Tags: Amyrt’s, AP103, Dystrophic Epidermolysis Bullosa (DEB), receives, Treatment, US FDA’s

Aurobindo Pharma Sign Agreement with COVAXX to Develop and Commercialize COVID-19 Vaccine UB-612 for India and UNICEF

Published: Dec 24, 2020 | Tags: Agreement, Aurobindo, Commercialize, COVAXX, COVID-19, Develop, India, Pharma, Sign, UB-612, UNICEF, vaccine

Innovent’s Byvasda (Bevacizumab Biosimilar) Receive NMPA’s Approval for Adult Recurrent Glioblastoma

Published: Dec 28, 2020 | Tags: Adult Recurrent Glioblastoma, approval, BYVASDA (Bevacizumab Biosimilar) Treatment, Innovent, NMPA

Innovent’s Sulinno (Adalimumab biosimilar) Receives China’s NMPA Approval for Pediatric Plaque Psoriasis and Non-infectious Uveitis

Published: Dec 23, 2020 | Tags: Adalimumab Biosimilar, Innovent, NMPA’s Approval, Non-infectious Uveitis, panuveitis in adults, Pediatric Plaque Psoriasis, posterior uveitis, Receive, Sulinno

Related Post: PharmaShots Weekly Snapshots (Dec 21-23, 2020)

The post PharmaShots Weekly Snapshots (Dec 28- 31, 2020) first appeared on PharmaShots.

Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen

Shots:

  • The company reported encouraging initial data from an ongoing P-I/II/III trial of its casirivimab + imdevimab (8,000/2,400mg) in hospitalized COVID-19 patients requiring low-flow oxygen. The results passed the futility analysis as seronegative patients treated with the Ab cocktail had a lower risk of death or receiving mechanical ventilation
  • In seronegative patients, the cocktail reduced the time-weighted average daily viral load through day 7 by -0.54 log10 copies/mL & through day 11 by -0.63 log10 copies/mL, at day 5, the relative reduction vs PBO was -1.1 log10 copies/mL
  • Both the Ab cocktail doses were well-tolerated. The Ab cocktail is designed to block the infectivity of SARS-CoV-2

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Knowledge Ecology International

The post Regeneron’s Antibody Cocktail Demonstrate Promising Results in Hospitalized Patients on Low-Flow Oxygen first appeared on PharmaShots.

EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed

UK-based EUSA Pharma has begun a late-stage trial of its antibody siltuximab in COVID-19, hoping that the IL-6 inhibitor will succeed where class rivals from Roche and Sanofi/Regeneron have failed.

Hertfordshire-based EUSA said recruitment has begun in phase 3 trial involving patients with COVID-19 previously treated with corticosteroids and other respiratory viruses associated with serious respiratory complications.

This pivotal study is designed to confirm results from the smaller SISCO study that investigated siltuximab plus standard of care in COVID-19 patients with serious respiratory complications.

Primary outcome of the SILVAR study will be all-cause 28-day mortality.

Siltuximab is an IL-6 inhibiting drug that was originally developed and marketed by the Johnson & Johnson’s Janssen unit for the rare disorder idiopathic multicentric Castleman’s disease.

EUSA Pharma bought global rights to the drug from Janssen in $115 million.

Roche and Sanofi/Regeneron have already tried to alleviate symptoms with their respective IL-6 drugs, Actemra (tocilizumab) and Kevzara (sarilumab), but trials did not produce supportive results.

EUSA said that unlike previous studies of agents targeting the IL-6 signalling pathway, the SILVAR study has been rationally designed to select those hospitalised patients still suffering from serious viral acute respiratory distress syndrome (ARDS).

Patients selected will be in a hyperinflammatory state that will most likely benefit from the addition of an immunomodulator, such as siltuximab.

Respiratory failure from ARDS is the leading cause of mortality in patients with COVID-19.

Siltuximab binds to and neutralises IL-6, a chemical signal in the body that is recognised as a key driver of ARDS in COVID-19 and other respiratory infections.

The SISCO trial earlier this year in COVID-19 compared 30 patients treated with siltuximab with 30 matched controls, and showed that treatment with the drug led to a 54% reduction in risk of 30-day all-cause mortality.

EUSA Pharma’s CEO Lee Morley said: “This clinical trial represents an important step in finding a solution for hospitalised patients with serious respiratory complications due to an over reactive immune response to (coronavirus) infection that is not fully responsive to corticosteroid therapy, as well as those with any other respiratory virus infection associated with serious ARDS.”

Feature image courtesy of Rocky Mountain Laboratories/NIH

The post EUSA Pharma hopes IL-6 drug will succeed in COVID-19 where rivals failed appeared first on .

Sanofi on notice as FDA reviews GSK’s Nucala for nasal polyps

Sanofi and Regeneron’s Dupixent has had the US market for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) mainly to itself since June 2019, but GlaxoSmithKline’s Nucala is now breathing down its neck.

The FDA has started its review of Nucala (mepolizumab) for the inflammatory condition, which results in the growth of nasal polyps in the nose that can obstruct airflow and cause mucus discharge, sometimes requiring surgical intervention.

In severe cases, polyps recur, so patients have to undergo multiple operations that according to GSK progressively become less effective and more risky.

The anti-IL-5 antibody is already approved by the FDA for severe asthma and two other conditions – hypereosinophilic syndrome (HES) and eosinophilic granulomatosis with polyangiitis – and is one of GSK’s top growth products with sales rising 28% to more than $930 million in the first nine months of this year.

If approved, it will be the first biologic challenger to Dupixent (dupilumab) – which has a different mechanism of action targeting IL-4 and IL-13 – and would also keep Nucala ahead of IL-5 class rivals like Teva’s Cinqair (reslizumab) and AstraZeneca’s Fasenra (benralizumab) that are challenging it in asthma.

The FDA’s review centres on the SYNAPSE trial, which involved 400 patients with a history of previous surgery who were in need of another procedure due to growing polyps and severe symptoms.

The drug improved both the size of nasal polyps at week 52 and in nasal obstruction during weeks 49-52, compared to placebo when added to standard of care, and extended the time to surgery by 57%.

Standard care for CRSwNP consists of corticosteroids in the nose, after surgery and systemic corticosteroids, but these often lack efficacy.

AZ reported positive results with Fasenra in CRSwNP in September, so may not be far behind with its own regulatory filings, and has also started to catch up with first-to-market Nucala in sales terms, growing 34% to $666 million in the first three quarters of 2020.

Regeneron meanwhile said last month that CRSwNP has been helping to drive increased sales of Dupixent, with a “strong uptick” in prescribing for this indication this year as well as a good performance in other uses like atopic dermatitis that drive it to more than $1.1 billion in global sales in the third quarter alone.

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PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020)

Richter Acquires Janssen’s Evra Transdermal Contraceptive Patch Assets for $263.5M

Published: Dec 3, 2020 | Tags: Asset Purchase Agreement, Evra, Gedeon Richter, Janssen Pharmaceutical, Signs, Transdermal Contraceptive Patch Assets, Treat

Jazz Pharma and PharmaMar’s Zepzelca Fail to Meet its Primary Endpoint in P-III ATLANTIS Study for SCLC

Published: Dec 3, 2020 | Tags: ATLANTIS, Doxorubicin, Jazz Pharma, P-III, patients, PharmaMar, results, SCLC, study, Zepzelca

reMYND Commences P-l Study of RES19-T for Alzheimer’s Disease

Published: Dec 3, 2020 | Tags: Alzheimer, Commencement, First-in-Human, P-l, reMYND, RES19-T, Treatment, Trial

Abbott’s FreeStyle Libre 2 Receives Health Canada’s Approval for Adults and Children with Diabetes

Published: Dec 2, 2020 | Tags: Abbott, Adults, approval, canada, Children, Diabetes, FreeStyle Libre 2, health, receives

Exactech Acquires Muvr and its Digital Health Tech for Orthopedic Practices

Published: Dec 2, 2020 | Tags: Acquires, Exactech, Muvr Labs, Orthopedic

Janssen Reports BLA Submission of Amivantamab to the US FDA for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations

Published: Dec 3, 2020 | Tags: Janssen, Reports, BLA Submission, Amivantamab, US FDA, Metastatic NSCLC, EGFR Exon 20 Insertion Mutations

Merck KGaA Collaborates with Artios Pharma for DNA Damage Cancer Therapies

Published: Dec 3, 2020 | Tags: Agreement, Artios Pharma, Damage, DNA, Merck KGaA, Novel, Oncology, Response, Signs, Targets

Janssen Acquires Rights to Hemera’s HMR59 for Late-Stage Age-Related Macular Degeneration

Published: Dec 2, 2020 | Tags: Acquires, Age Related Macular Degeneration, Biosciences, Gene, Hemera, Janssen, Late, Novel, Pioneering, Rights, Solutions, Stage, therapy, Treatment

AstraZeneca to Unveil its Robust Pipeline of Breast Cancer at SABCS

Published: Dec 3, 2020 | Tags: AstraZenca, DESTINY-Breast01, Enhertu, HER2 -Positive Metastatic Breast Cancer, HR, P-l, P-ll, reports, results, SERD AZD9833, SERENA-1 Study

AbbVie Collaborates with Frontier Medicines to Develop Novel Therapies and E3 Degraders Against Difficult-to-Drug Targets

Published: Dec 2, 2020 | Tags: AbbVie, Agreement, Develop, Discover, E3 Degraders, Frontier Medicines, Novel Therapies, Sign

Roche’s Elecsys Anti-SARS-CoV-2 S Receives the US FDA’s EUA to Detect Ab Against SARS-CoV-2 Spike Protein

Published: Dec 2, 2020 | Tags: (Anti-SARS-CoV-2 S), COVID-19, Elecsys, EUA, Receive, Roche’s, US FDA’s

Pfizer & BioNTech Receives MHRA’s EUA for BNT162b2 Against COVID-19

Published: Dec 2, 2020 | Tags: Against, BioNTech, BNT162b2, COVID-19 COVID-19, EUA, MHRA, Pfizer, receives, Regulatory, UK

Roche’s Gavreto (pralsetinib) Receives the US FDA’s Approval for Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancers

Published: Dec 2, 2020 | Tags: (pralsetinib), Advanced or Metastatic RET-Mutant, Gavreto, receives, RET Fusion-Positive Thyroid Cancers, Roche’s, US FDA’s Approval

AstraZeneca to Divest European Rights of Crestor (rosuvastatin) to Grünenthal for ~$350M

Published: Dec 1, 2020 | Tags: $350M, Acquire, Agreement, AstraZeneca, CRESTOR, European, Grünenthal, Rights, rosuvastatin, Signs

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Published: Dec 1, 2020 | Tags: Casirivimab, Collaborates, COVID-19 Antibody Cocktail, Delivery, Gene Therapy Platform, Imdevimab, Investigate, Penn, Regeneron

Boston Scientific to Divest BTG’s Specialty Pharma Business for ~$800M

Published: Dec 1, 2020 | Tags: Agreement, Boston, BTG, business, International, Pharmaceuticals, Scientific, Sell, Signs, Specialty, Stark

BioNTech and Pfizer Report CMA Submission of BNT162b2 to EMA for COVID-19

Published: Dec 1, 2020 | Tags: application, BioNTech, BNT162b2, CMA, Covid-19 Vaccine, EMA, Pfizer, Submitted

Genentech and Novartis’s Xolair (omalizumab) Receives the FDA’s Approval for Adults with Nasal Polyps

Published: Dec 1, 2020 | Tags: Adults, approval, Genentech Xolair, Nasal Polyps, Novartis, omalizumab, receives, US FDA

Eisai Sign a Research Agreement with Wren Therapeutics to Discover Potential Treatment for Synucleinopathies

Published: Nov 30, 2020 | Tags: Discover, Eisai, Novel Small Molecule, Research Agreement, Sign, Synucleinopathies, Wren Therapeutics

 AstraZeneca Initiates P-IIb Study of ION449 (AZD8233) to Lower LDL-cholesterol

Published: Nov 30, 2020 | Tags: Antisense, AstraZeneca, Initiates, ION449, Ionis, LDL-C, Lower, Medicine, P-IIb, PCSK9, reports, study, Targeting

Kaia Health Allied with Chiesi Group to Commercialize COPD App in Europe

Published: Nov 30, 2020 | Tags: Agreement, Chiesi Group, Europe, Kaia Health, Sign

Member of COVID R&D Alliance Report the First Patient Enrollment in COMMUNITY Study

Published: Dec 1, 2020 | Tags: Amgen, COMMUNITY, COVID-19, enrolled, First, Patient, patients, reports, Takeda, Trial, UCB

Sanofi’s Dupixent (dupilumab) Receives EC’s Approval for Children with Severe Atopic Dermatitis

Published: Nov 30, 2020 | Tags: (dupilumab), Atopic Dermatitis, Dupixent, European Commission Approval, receives, Sanofi’s

Moderna to Seek the FDA and EMA’s EUA for mRNA-1273 and Shows 100% Efficacy in P-III COVE-Study

Published: Nov 30, 2020 | Tags: 100%, 94.1%, COVID-19, Effective, EUA, Filing, Moderna, mRNA, Severe, Shows, Today, Us FDA, vaccine

AstraZeneca’s Forxiga (dapagliflozin) Receives MHLW’s Approval for Chronic Heart Failure

Published: Nov 30, 2020 | Tags: approval, AstraZeneca, Chronic Heart Failure, dapagliflozin, Forxiga, Japan, MHLW, receives, Treatment

AbbVie and Eisai’s Humira (adalimumab) Receives MHLW’s Approval for Pyoderma Gangrenosum

Published: Nov 27, 2020 | Tags: (adalimumab), AbbVie, Additional, Eisai, Humira, Indication, MHLW Approval, Pyoderma Gangrenosum, receives

Shionogi and Nagasaki University Collaborate with the Kitasato Institute for Antimalarial Drugs

Published: Nov 25, 2020 | Tags: Agreement, Antimalarial, drugs, Kitasato Institute, Nagasaki, Shionogi, Signs, University

Shionogi Receives MHLW’s Approval for Xofluza’s sNDA to Treat Post-Exposure Prophylaxis of Influenza Virus Infection

Published: Nov 27, 2020 | Tags: (baloxavir marboxil), approval, Infection, Influenza Virus, MHLW, Post-Exposure Prophylaxis, receives, Shionogi, sNDA, Treat, Xofluza

Moderna Amends its Agreement with UK Government for an Additional 2M Doses of COVID-19 Vaccine

Published: Nov 29, 2020 | Tags: 2M, Additional, Against, Agreement, Amends, COVID-19, doses, Government, Moderna, mRNA, mRNA-1273, UK, vaccine

Dr. Reddy’s to Divest Select Anti-Allergy brands to Dr. Reddy’s in Russia and Other CIS Countries

Published: Nov 28, 2020 | Tags:  Acquire, Dr. Reddy, Glenmark, Kazakhstan, Russia, Ukraine, Uzbekistan

Related Post: PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

The post PharmaShots Weekly Snapshot (Nov 30 – Dec 04, 2020) first appeared on PharmaShots.

Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform

Shots:

  • Penn allied with Regeneron to investigate Ab cocktail (casirivimab & imdevimab) to prevent COVID-19 infection when delivering intranasally via AAV vectors
  • The collaboration b/w Wilson and Penn’s GTP and Regeneron will have two phases. The first phase will include the validation of the effectiveness of Abs delivered via AAV in a large animal model challenge study. If successful, the research team will complete studies to support the filing of IND to the FDA
  • Regeneron’s Ab cocktail (casirivimab & imdevimab) is studied in clinical trials for the prevention of COVID-19 and has received the US FDA’s EUA in certain high-risk patients with mild to mod. COVID-19

Click here ­to­ read full press release/ article | Ref: Penn Medicine | Image: LaingBuisson News

The post Regeneron Collaborates with Penn to Explore Intranasal Delivery of COVID-19 Ab Cocktail via Gene Therapy Platform first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 23 – 27, 2020)

Merck Collaborates with Siemens for the Digitalization of Production

Published: Nov 26, 2020 | Tags: Agreement, Collaborative, Digitalization, Merck, Siemens, Sign

CoSara Receives CDSCO’s Approval for its Saragene COVID-19 2-Gene Multiplex Test

Published: Nov 26, 2020 | Tags: approval, CDSCO, Co-Diagnostics JV CoSara, COVID-19 2-gene multiplex RT-PCR, India, Manufacture, receives, Saragene, Sell, Test

PostEra Collaborates with NeuroLucent to Identify Therapies for Alzheimer’s Disease

Published: Nov 25, 2020 | Tags: Agreement, Alzheimer Disease, Collaborative, Develop, NeuroLucent, Novel, PostEra, Sign, Treatment

BASE10 Collaborates with DNA Link to Support Authorization of COVID-19 IgG Antibody Test at the Point of Care

Published: Nov 26, 2020 | Tags: BASE10, Collaborates, DNA, Link, Support, Authorization, COVID-19, IgG Antibody, Test, Point, Care

Egle Identifies First Novel Regulatory T-cell Targets Under its Collaboration with Takeda

Published: Nov 26, 2020 | Tags: Agreement, Alliance, Egle, First, Identifies, Novel, Regulatory, Research, T-cell, Takeda, Targets, therapeutics

Merck KGaA Reports EMA’s Validation of MAA for Tepotinib to Treat Advanced NSCLC with METex14 Skipping Alterations

Published: Nov 26, 2020 | Tags: Advanced NSCLCs, EMA’s Validation, MAA, Merck, reports, Tepotinib, Treat

Y-mAbs’ Danyelza (naxitamab-gqgk) Receives the US FDA’s Approval for Neuroblastoma

Published: Nov 25, 2020 | Tags: (naxitamab-gqgk), approval, Danyelza, Neuroblastoma, receives, US FDA’s, Y-mAbs Therapeutics

CorticoMetrics’s THINQ Receives the US FDA’s 510(k) Clearance for MRI Brain Volumetric Reporting

Published: Nov 24, 2020 | Tags: 510(k), Brain, Clearance, CorticoMetrics, MRI, receives, Reporting, THINQ, Us FDA, Volumetric

BioNTech and Fosun Pharma Initiate P-ll Study of BNT162b2 Against COVID-19 in China

Published: Nov 25, 2020 | Tags: BioNTech, BNT162b2, China, Clinical Trial, Covid-19 Vaccine, Fosun Pharma, Lead mRNA, P-ll, Resumes

Urovant’s Vibegron Fails to Meet its Primary Endpoint in P-IIa Study for IBS Pain

Published: Nov 24, 2020 | Tags: Irritable Bowel Syndrome, P-IIa, reports, results, Sciences, study, Treatment, Urovant, Vibegron

Bio-Thera Reports MAA Submission to EMA for BAT1706 a Proposed Biosimilar to Avastin

Published: Nov 25, 2020 | Tags: Avastin, BAT1706 Proposed Biosimilar, Bio-Thera Solutions, Cancer, EMA, Marketing Authorization Application, Submits

Janssen’s Tremfya (guselkumab) Receives EC’s Approval as a First in Class Treatment for Active Psoriatic Arthritis

Published: Nov 25, 2020 | Tags: Active Psoriatic Arthritis (PsA), EC’s Approval, First in Class, guselkumab, Janssen’s, receives, Treatment, Tremfya

Bausch Health Initiates Second P-III Study for NOV03 (perfluorohexyloctane) to Treat DED Associated With MGD

Published: Nov 24, 2020 | Tags: Associated, Bausch Health, Disease, Dry Eye, Initiates, Investigational, MGD, NOV03, P-III, Second, study, Treatment

Evotec Collaborates with Rappta Therapeutics to Focus on Oncology Target

Published: Nov 24, 2020 | Tags: Agreement, Development, Discovery, Evotec, Focused, Oncology, Rappta, Signs, Target, therapeutics

Russia’s Sputnik V Demonstrates 91.4% Efficacy Against COVID-19

Published: Nov 24, 2020 | Tags: COVID-19, Gamaleya Center, P-lll Study, RDIF, reports, results, Second Interim Analysis, Sputnik V

Alvotech and Alvotech & CCHT Sign an Exclusive Commercialization Agreement with Yangtze River for Eight Biosimilars in China

Published: Nov 24, 2020 | Tags: Alvotech, CCHT, China, Eight Biosimilar Medicines, Exclusive Commercialization Agreement, Sign, Yangtze River

Alnylam’s Oxlumo (lumasiran) Receives the US FDA’s Approval for Treatment of Primary Hyperoxaluria Type 1 in Pediatric and Adult Patients

Published: Nov 24, 2020 | Tags: Adult, Alnylam, approval, Hyperoxaluria, Lumasiran, OXLUMO, patients, Pediatric, Primary, receives, Treatment, Type 1, Us FDA

BMS’ Opdivo (nivolumab) Receives EC’s Approval as 2L Treatment for Unresectable Advanced and Metastatic Esophageal Squamous Cell Carcinoma

Published: Nov 24, 2020 | Tags: 2L Treatment, Bristol Myers Squibb, EC’s Approval, Metastatic Esophageal Squamous Cell Carcinoma (ESCC), Nivolumab, Opdivo, receives, Unresectable Advanced

Selvita to Acquire Fidelta from Galapagos for ~$37M

Published: Nov 23, 2020 | Tags: $37.08M, Acquire, Fidelta, Galapagos, Selvita

Targovax Reports Results of ONCOS-102 in P-l/ll Study as 1L and 2L Treatment for Malignant Pleural Mesothelioma

Published: Nov 24, 2020 | Tags: (SoC), 1L and 2L Treatment, Malignant Pleural Mesothelioma (MPM), ONCOS-102, P-l/ll Study, reports, results, SITC Annual Meeting, Standard of Care, Targovax

Roche’s Xofluza (baloxavir marboxil) Receives the US FDA’s Approval for Post-Exposure Prevention of Influenza

 Published: Nov 24, 2020 | Tags: approval, baloxavir marboxil, Contact, Following, Infected,  Influenza, Person, Prevention, receives, Roche, Us FDA, Xofluza

Baxter’s Homechoice Claria APD System Receives the US FDA’s 510 (k) Clearance for Kidney Failure

Published: Nov 23, 2020 | Tags: Baxter’s, Claria Automated Peritoneal Dialysis (APD) System, Clearance, Homechoice, Kidney Failure, receives, US, US FDA’s 510 (k)

Schrödinger Signs a $2.7B Agreement with BMS to Develop and Commercialize Therapies in Multiple Disease Areas

Published: Nov 23, 2020 | Tags: Agreement, Areas, BMS, Commercialize, Develop, Discover, Disease, Multiple, Schrödinger, Signs, therapeutics

Merck to Acquire OncoImmune for $425M

Published: Nov 23, 2020 | Tags: Acquire, CD24Fc program, Merck, OncoImmune

AstraZeneca’s AZD1222 Meets its Primary Endpoint in Preventing COVID-19

Published: Nov 23, 2020 | Tags: AstraZeneca, AZD1222, COV002, COV003, COVID-19, P-II/III, P-III, Positive, Preventing, reports, results, Trial, vaccine

Eli Lilly Signs an Exclusive Agreement with Precision BioSciences on Genome Editing Research

Published: Nov 20, 2020 | Tags: Develop of Potential, Genetic Disorders, License Agreement, Lilly, Precision, Research, Research Collaboration, Signs, Vivo Therapies

Eiger’s Zokinvy (lonafarnib) Receives the US FDA’s Approval for Treatment of Progeria and Processing-Deficient PL

Published: Nov 20, 2020 | Tags: approval, Deficient, Eiger, lonafarnib, PL, Processing, Progeria, receives, Treatment, Us FDA, Zokinvy

Innovent Reports Results of Tyvyt + Byvasda (biosimilar, bevacizumab) in P-lll ORIENT-32 Study as 1L Treatment for HCC

Published: Nov 22, 2020 | Tags: 1L treatment, Advanced Hepatocellular Carcinoma (HCC), Byvasda, ESMO ASIA Virtual Congress 2020, Innovent, ORIENT-32 Study, P-lll, reports, results, Tyvyt

Lilly’s Bamlanivimab (LY-CoV555) Receives Health Canada’s Interim Authorization as a Treatment for COVID-19

Published: Nov 20, 2020 | Tags: Authorization, Bamlanivimab, canada, COVID-19, health, Interim, Lilly, LY-CoV555, receives, Treatment

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Published: Nov 21, 2020 | Tags: Casirivimab, COVID-19, EUA, Imdevimab, patients, receives, Regeneron, US FDA’s

Related Post: PharmaShots Weekly Snapshot (Nov 16-20, 2020)

The post PharmaShots Weekly Snapshot (Nov 23 – 27, 2020) first appeared on PharmaShots.

Regeneron’s COVID-19 antibody cocktail gets US emergency licence

Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available.

The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues.

Formerly known as REGN-COV2 or REGEN-COV2, the cocktail can be used for mild to moderate COVID-19 in adults and children at least 12 years of age and weighing at least 40 kg.

Doctors now have another option to choose from to combat the disease, following EUAs for drugs such as Eli Lilly’s baricitinib and Gilead’s Veklury (remdesivir).

To be eligible for Regeneron’s combination, patients must have received positive results of direct SARS-CoV-2 viral testing and be considered at high risk for progressing to severe COVID-19 and/or hospitalisation.

Clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

As part of the Operation Warp Speed project to rapidly develop therapies and vaccines against the disease, the US government and Regeneron a supply agreement for the cocktail, which was famously used to treat president Donald Trump after he became infected.

Regeneron will coordinate with state authorities to allocate the cocktail on a weekly basis, based on prevalence of the disease in each state.

The first 300 doses will be provided at no cost to patients, although hospitals and clinics may add their own fees.

AmerisourceBergen will be the first national distributor to begin delivering the therapy.

Earlier this month, Regeneron had to modify a trial protocol for the therapy after independent safety experts said it should not be given to high-risk patients after an undisclosed safety issue emerged in testing.

In late October, Eli Lilly said it wouldn’t resume a trial of its rival antibody therapy in hospitalised patients after National Institutes of Health researchers said it wouldn’t help.

AstraZeneca is developing a long-acting antibody therapy combination in the US and other countries to prevent infection happening and as a therapy for those already infected.

Regeneron’s antibodies were designed to combat SARS-CoV-02 using the company’s proprietary genetically modified mice, which have been engineered to have a human immune system.

The antibodies bind non-competitively to the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

The post Regeneron’s COVID-19 antibody cocktail gets US emergency licence appeared first on .

Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19

Shots:

  • The US FDA has issued a EUA for casirivimab (1,200mg) + imdevimab (1,200mg) administered together for mild to mod. COVID-19 in adults and pediatric patients aged ≥12yrs. weighing at least 40kg [~88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19
  • The EUA is based on a P-II study that showed a reduction in hospitalization or ER visits in patients at high risk for disease progression within 28days after treatment and a reduction in viral loads
  • Initial doses of Ab cocktail will be made available to ~300,000 patients, with no medication out-of-pocket costs, under the US government allocation program

Click here ­to­ read full press release/ article | Ref: Regeneron | Image: Fox Business

The post Regeneron’s Casirivimab and Imdevimab Receive the US FDA’s EUA as the First Combination Therapy for COVID-19 first appeared on PharmaShots.

Insights+: The US FDA New Drug Approvals in October 2020

The US FDA has approved 4 NDAs and 1 BLA in Oct 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 90 novel products so far in 2020, including 5 in Oct 2020. Additionally, last year in 2019, the US FDA has approved 48 novel products. We have compiled a list of a total of 5 new drugs approved by the US FDA in Oct 2020.

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Received the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: Approval, Atoltivimab, Ebolavirus, Firs,t Inmazeb, Maftivimab, Odesivimab, Receives, Regeneron, Treatment, US FDA

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

Nevakar’s Ephedrine Sulfate Injection Received the US FDA’s Approval as Ready-To-Use Vials

Published: Oct 22, 2020 | Tags: Nevakar, Ephedrine Sulfate, Injection, Receives, US FDA, Approval, Ready to Use, Vials

  • Nevakar received US FDA’s approval to market Ephedrine Sulfate Injection (50mg/10 ml) in a ready to use vial presentation and it is the 1st approval under collaboration bw Nevakar and Endo for the development of sterile injectable product in the US and Canada
  • Nevakar to develop and obtain FDA approval for these products and Par Pharmaceuticals Sterile Products division will launch and distribute the products
  • The company is focused on developing and commercializing innovative products to address unmet medical needs, thereby improving patient care and quality of life

Gilead’s Veklury (remdesivir) Received the US FDA’s Approval as the First Treatment for COVID-19

Published: Oct 23, 2020 | Tags: COVID-19, Gilead, Receives, Remdesivir, US FDA, Approval, Veklury

  • The approval is based on three studies including P-lll ACTT-1 study assessing the efficacy and safety of a 10-day treatment course of Veklury vs PBO in 1063 hospitalized patients with confirmed SARS-CoV-2 infection and mild, moderate or severe COVID-19 receiving the treatment with SOC. The other two studies include two P-II OLE studies (SIMPLE-Severe trial & SIMPLE-Moderate trial)
  • ACTT-1 trial results: improvement in time to recovery in overall study population & in patients who required oxygen (10 vs 15days & 11 vs 18days); reduction in disease progression in patients needing oxygen, reduction in new mechanical ventilation or ECMO (13% vs 23%)
  • Additionally, FDA also issued a new EUA for the use of Veklury to treat hospitalized pediatric patients aged <12yrs. weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to <40 kg with suspected or laboratory confirmed COVID-19 for whom use of an IV agent is clinically appropriate. Veklury is now the 1st and only approved COVID-19 treatment in the US

Kala Pharmaceuticals’ Eysuvis (loteprednol etabonate ophthalmic suspension) Received US FDA’s Approval for Dry Eye Disease

Published: Oct 27, 2020 | Tags: Kala Pharmaceuticals, Eysuvis, Loteprednol, Etabonate, Ophthalmic, Suspension, US FDA, Dry Eye Disease

  • The approval is based on results from four clinical trials, including three P-III trials and one P-II trial, that demonstrated significant improvements in both the signs and symptoms of dry eye disease
  • The approval has made Eysuvis, the 1st ocular corticosteroid for the treatment of dry eye disease and the 1st drug approved specifically for the short-term (up to 2 wks.) treatment of the signs and symptoms of dry eye disease
  • Eysuvis utilizes Kala’s Ampplify mucus-penetrating particle (MPP) drug delivery technology to enhance penetration of loteprednol etabonate into target tissue on the ocular surface. The company plans to launch Eysuvis in the US by the end of the year 2020

Chiesi’s Bronchitol (mannitol) Inhalation Powder Received US FDA’s Approval for Cystic Fibrosis

Published: Oct 30, 2020 | Tags: Chiesi, Bronchitol, Mannitol, Inhalation, Powder, Receives, US FDA, Approval, Cystic Fibrosis, Pulmonary

  • In the three large-scale global clinical trials assessing Bronchitol in 761 patients, sustained improvement in FEV1 (Forced Expiratory Volume) with Bronchitol use vs. control group was observed
  • Bronchitol is currently approved and marketed in Australia, Italy, Germany, Russia, and several other countries. Additionally, the company anticipates launching Bronchitol in the US in Mar 2021
  • Bronchitol (mannitol) inhalation powder is a sugar alcohol and also the 1st and only inhaled dry powder indicated as add-on maintenance therapy to improve pulmonary function in CF patients aged 18 yrs. of age and older

Related Post: Insights+: The US FDA New Drug Approvals in September 2020

The post Insights+: The US FDA New Drug Approvals in October 2020 first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Nov 02-06, 2020)

AstraZeneca’s Brilinta (ticagrelor) Receives the US FDA’s Approval to Reduce the Risk of Stroke in Patients with an Acute Ischemic Stroke or High-Risk Transient Ischemic Attack

Published: Nov 6, 2020 | Tags: AstraZeneca, Brilinta, ticagrelor, Receives, US FDA, Approval, Acute, High,Risk, Transient, Ischaemic, Stroke

Novo Nordisk to Acquire Emisphere Technologies for $1.8B

Published: Nov 6, 2020 | Tags: Novo Nordisk, Acquire, Emisphere Technologies, $1.8B

AstraZeneca’s Forxiga (dapagliflozin) Receives EC’s Approval for Heart Failure

Published: Nov 5, 2020 | Tags: AstraZeneca’s, Forxiga, (dapagliflozin), Receives, EU, Approval, Heart Failure

AstraZeneca and MSD’s Lynparza (olaparib) Receive EU’s Approval as 1L Maintenance Treatment for HRD-Positive Advanced Ovarian Cancer

Published: Nov 5, 2020 | Tags: AstraZeneca, MSD, Lynparza, Olaparib, Receives, EU, Approved, HRD, Positive, Advanced, Ovarian, Cancer

Merck KGaA Collaborates with Iktos to Deploy AI in New Drug Design

Published: Nov 5, 2020 | Tags: Iktos, Signs, Agreement, Merck, KGaA, AI, New, Drug, Design

Formycon Reports BLA Resubmission Strategy for FYB201 (biosimilar, ranibizumab)

Published: Nov 5, 2020 | Tags: Formycon, Reports, BLA, Resubmission, Strategy, Lucentis, Biosimilar, FYB201

Novartis Reports Results of Cosentyx (secukinumab) in P-IIIb ULTIMATE Study for Psoriatic Arthritis

Published: Nov 5, 2020 | Tags: Cosentyx, Novartis, P-IIIb, patients, Psoriatic Arthritis, reports, results, secukinumab, study, ULTIMATE

Merck to Acquire VelosBio for $2.75B

Published: Nov 5, 2020 | Tags: $2.75B, Acquire, Merck, Oncology Pipeline, VelosBio

Innovent and Lilly Report Results of Tyvyt (sintilimab) in Seven Clinical Studies to be Presented at the ESMO ASIA Congress 2020

Published: Nov 5, 2020 | Tags: 2020, 7, Asia, Clinical, Congress, ESMO, Injection, Innovent, Lilly, Presents, results, Sintilimab, Studies, Tyvyt

Coloplast Acquires Nine Continents Medical

Published: Nov 4, 2020 | Tags: Coloplast, Acquires, Nine Continents Medical

Novavax Collaborates with Commonwealth of Australia to Supply 40M doses of NVX-CoV2373 for COVID-19

Published: Nov 4, 2020 | Tags: Novavax, Collaborates, Commonwealth, Australia, Supply, 40M, Doses, NVX-coV2373, COVID-19

BioInvent Presents New Clinical and Preclinical Data of BI-1206 at ASH Annual Meeting

Published: Nov 5, 2020 | Tags: ASH Annual Meeting, BI-1206, BioInvent, Follicular Lymphoma Mantle Cell Lymphoma, Marginal Zone Lymphoma, P-l/lla Study, reports, results

Jounce Stops Enrollment in P-II EMERGE Study Evaluating Vopratelimab for Lung Cancer

Published: Nov 4,2020 | Tags: Jounce Therapeutics, P-II EMERGE trial, Program, reports, Update, Vopratelimab

Biomarin Reports the US FDA’s Acceptance of Vosoritide’s NDA to Treat Children with Achondroplasia

Published: Nov 4, 2020 | Tags: Acceptance, Achondroplasia Regulatory, BioMarin, Children, FDA, NDA, reports, US, Vosoritide

CEPI to Invest ~$328M in Clover’s COVID-19 Vaccine Candidate

Published: Nov 3, 2020 | Tags: CEPI, Clover Biopharmaceuticals, Covid-19 Vaccine, Expand, Fund, Partnership

Abbott to Launch its Cardiac Mapping Platform in Europe and Australia

Published: Nov 2,2020 | Tags: Abbott, approval, CE Mark, EnSite X EP System, receives, TGA

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in P-III POETYK PSO-1 Study for Plaque Psoriasis

Published: Nov 4,2020 | Tags: BMS, BMS-986165, Deucravacitinib, Moderate, P-III, patients, Plaque, POETYK PSO-1, Positive, Psoriasis, reports, results, Severe, study

Boston Scientific’s Ranger DCB Receives the US FDA’s Approval for Peripheral Artery Disease in the SFA and PPA 

Published: Nov 4,2020 | Tags: approval, Boston Scientific, DCB, patients, Peripheral Artery Disease, PPA, Range, receives, SFA, Treatment, Us FDA

Novartis Reports Results of Kisqali (ribociclib) in P-III MONALEESA-7 Study in Women with HR+/HER2- Advanced Breast Cancer

Published: Nov 3,2020 | Tags: Advanced, breast, Cancer, HR+/HER2, Kisqali, MONALEESA-7, Novartis, P-III, reports, results, ribociclib, study, Women

Tetra Therapeutics Reports Positive Results of BPN14770 in P-II Study for Fragile X Syndrome

Published: Nov 3, 2020 | Tags: BPN14770, FXS, P-II, patients, Positive, reports, results, study, Tetra Therapeutics

Roche’s Tecentriq (atezolizumab) + Avastin (bevacizumab) Receive the EC’s Approval for Unresectable Hepatocellular Carcinoma

Published: Nov 3, 2020 | Tags: (atezolizumab), (bevacizumab), Aavastin, EU Approval Unresectable Hepatocellular Carcinoma (HCC), receives, Roche’s, Tecentriq

Celltrion Presents Results of CT-P17 (biosimilar, adalimumab) in P-III Study for RA at ACR 2020

Published: Nov 3, 2020 | Tags: 2020, ACR, Celltrion Healthcare, Convergence, CT-P17, P-III, Positive, Presents, RA, results, study, Treatment

Janssen Reports sNDA Submission of Paliperidone Palmitate 6-Month (PP6M) to the US FDA for Schizophrenia

Published: Nov 3, 2020 | Tags: (PP6M), Invega Sustenna, Invega Trinza, Janssen, NDA submission, reports, Us FDA

AstraZeneca and Fusion Collaborate to Develop and Commercialize Radiopharmaceuticals and Combination Therapies for Cancer

Published: Nov 3, 2020 | Tags: AstraZeneca, Cancer, Collaborate, Combination Therapies, Commercialize, Develop, Fusion, Next-Generation Radiopharmaceuticals

Novartis Reports Results of Aimovig (erenumab) in P-lV Study for Episodic and Chronic Migraine

Published: Nov 2, 2020 | Tags: Aimovig, Episodic and Chronic Migraine (HER-MES), erenumab, Novartis, P-lV Study, positive results, Report

Sun Pharma Reports Five Year Results of Ilumya (tildrakizumab-asmn) in P-III Studies for Moderate-to-Severe Plaque Psoriasis

Published: Nov 2, 2020 | Tags: 5-year, Ilumya, Moderate, P-III, patients, reports, results, reSURFACE 1, reSURFACE 2, Severe, Studies, Sun Pharma, tildrakizumab-asmn

 Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Published: Nov 2, 2020 | Tags: Fibrodysplasia Ossificans Progressiva, Garetosmab, LUMINA-1 Trial, P-ll, patients, Regeneron, REGN2477, Report, results

UCB Reports Results of Bimekizumab in P-III BE SURE Study for Moderate-to-Severe Psoriasis

Published: Nov 2, 2020 | Tags: BE SURE, Bimekizumab, Moderate, P-III, patients, Psoriasis, reports, results, Severe, study, UCB

Sanofi to Acquire Kiadis for ~$358M

Published: Nov 2, 2020 | Tags: $358.76M, Acquire, Kiadis, Offers, Sanofi

Medtronic Expands ENT Portfolio with the Acquisition of Ai Biomed and the Approval of NIM Vital Nerve Monitoring System

Published: Nov 2, 2020 | Tags: Acquires, Ai Biomed Corp., ENT Portfolio, Medtronic’s, NIM Vital, Parathyroid Detection System, receives, US FDA’s Approval

Related Post: PharmaShots Weekly Snapshot (Oct 26 – 30, 2020)

The post PharmaShots Weekly Snapshot (Nov 02-06, 2020) first appeared on PharmaShots.

Regeneron’s COVID-19 antibody cocktail therapy hits safety problem

Regeneron’s coronavirus antibody cocktail therapy against COVID-19, famously used to treat president Donald Trump, has hit a safety issue after independent safety experts recommended it should not be given to high-risk patients in a late-stage clinical trial.

It’s the latest blow for antibody therapies against COVID-19 after Eli Lilly last week announced it won’t resume a trial in hospitalised patients, after National Institutes of Health researchers concluded it wouldn’t help.

Regeneron said an Independent Data Monitoring Committee (IDMC) from the REGN-COV2 trial said that based on an unspecified safety signal and an “unfavourable risk benefit profile” the committee recommends a modification to the trial protocol.

The IDMC recommends further enrolment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold pending collection and analysis of further data from those already on the trial.

Regeneron remains blinded to the data and is implementing the recommendations.

The company has also informed the FDA, which is reviewing REGN-COV2 data for a potential Emergency Use Authorization in patients with mild-to-moderate outpatients at high risk for poor outcomes.

The data is also being shared with the independent committee monitoring the RECOVERY trial in the UK, which is testing the drug cocktail in hospitalised patients.

REGN-COV2 is split into four cohorts – patients on low-flow oxygen, patients not requiring oxygen, patients on high-flow oxygen and patients on mechanical ventilation.

The spotlight has been on antibody therapies for COVID-19 after it emerged early last month that Trump was treated with the Regeneron combination.

Regeneron’s therapy is based on two antibodies the company has developed to neutralise the virus.

The rationale is that by having a double therapy, the chances of the virus developing resistance to both parts of the drug are reduced.

AstraZeneca is to begin phase 3 trials of a long-acting antibody therapy combination in the US and other countries in the coming weeks, to prevent infection happening and as therapy for those already infected.

The post Regeneron’s COVID-19 antibody cocktail therapy hits safety problem appeared first on .

Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva

Shots:

  • Regeneron pauses dosing of the garetosmab (REGN2477) in the ongoing P-II LUMINA-1 study in patients with FOP. The pause is due to fatal serious AEs in the study during the open-label extension during which all patients received active treatment
  • Regeneron shared the update with the trial’s IDMC and regulatory authorities and will conduct a review of the study to better understand the benefit/risk profile of garetosmab in people with FOP
  • Garetosmab is a VelocImmune-derived mAb that binds and neutralizes Activin A, which is involved in the development of heterotopic bone in people with FOP

Click here to­ read the full press release/ article | Ref: Regeneron | Image: The Print

The post Regeneron Pauses Dosing of Garetosmab (REGN2477) in P-II LUMINA-1 Study for Fibrodysplasia Ossificans Progressiva first appeared on PharmaShots.

FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda

The FDA has started a priority review of Regeneron and Sanofi’s checkpoint inhibitor Libtayo in first-line non-small cell lung cancer (NSCLC), based on data they hope will carve out a niche for the drug in a highly-contested market.

PD-1 inhibitor Libtayo (cemiplimab) impressed oncologists earlier this year with results from a trial in previously-untreated NSCLC patients whose tumours had high levels of the PD-L1 biomarker, showing the drug reduced the risk of death by 32% compared to platinum chemotherapy.

Updated results from the study reported at the ESMO congress in September showed that among patients with confirmed PD-L1 expression of 50% or more – the patient group targeted in Sanofi and Regeneron’s marketing application – the mortality rate was reduced by 43%.

If the FDA cleared Libtayo by its deadline of 28 February, the drug will join the clutch of checkpoint inhibitors vying for a slice of the first-line NLSCLC market, nipping at the heels of Merck & Co/MSD’s mega-blockbuster Keytruda (pembrolizumab), the undisputed class leader in this form of lung cancer.

Libtayo is also under review by the EMA as a treatment for treatment-naïve NSCLC patients with PD-L1 expression of at least 50%, with a decision expected in the second quarter of 2021, according to Sanofi.

Libtayo was the sixth PD-L/PD-L1 inhibitor to reach the market, starting out as a therapy for an uncommon skin cancer called cutaneous squamous cell carcinoma (CSCC), but Sanofi and Regeneron are seeking to expand its use into first-line NSCLC as well as basal cell carcinoma (BCC), another form of skin cancer.

At the moment, the annual net sales of these drugs across all indications are around $25 billion, but about half of that comes from NSCLC, which means even a minor share of that market would be a big step up for Libtayo. Regeneron reported sales of the drug were around $155 million in the first half of 2020.

Keytruda is used mainly in combination with chemo in first-line NSCLC, based on  trial data showing a 51% reduction in death versus chemo alone – although it is also approved as a monotherapy – and has the advantage that it can be given to patients regardless of their PD-L1 status.

Sanofi and Regeneron are hoping that the impressive mortality data from their trial will allow Libtayo to vie for selection as treatment for higher PD-L1 expressors, but other rivals are also in the mix.

Bristol-Myers Squibb’s combination of PD-1 inhibitor Opdivo (nivolumab) and CTLA4 inhibitor Yervoy (ipilimumab) has now been approved by the FDA for two front-line NSCLC indications, both in May.

It was cleared as a monotherapy for patients with PD-L1 levels of 1% or more, and with “limited” chemo in all patients regardless of PD-L1 status, provided they have no EGFR or ALK mutations, which can be treated with targeted drugs.

Meanwhile, Roche’s PD-L1 drug Tecentriq (atezolizumab) has also picked up two approvals from the US regulator, one for the drug on its own in patients whose tumours express PD-L1, and a second alongside chemo in ‘all-comer’ patients with no EGFR or ALK mutations.

The post FDA sets Feb decision date for Libtayo lung cancer challenge to Keytruda appeared first on .

Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting

Shots:

  • The P-ll/lll trial involves assessing of REGN-COV2 (8gm/2.4gm) + SOC vs PBO + SOC in 524 patients with mild-to-moderate COVID-19 in an outpatient setting
  • The study met its 1EPs & 2EPs demonstrating a reduction in viral load and patient medical visits. Moreover, Regeneron is reviewing potential changes to dosing in the ongoing outpatient clinical trial given the current limited supply of REGN-COV2
  • REGN-COV2 is a combination of two mAbs (REGN10933 + REGN10987), designed specifically to block the infectivity of SARS-CoV-2. Additionally, Regeneron has shared results with the US FDA, which is reviewing a EUA submission for the REGN-COV2 low dose in adults with mild-to-moderate COVID-19 who are at high risk for poor outcomes

Click here to­ read full press release/ article | Ref: PRNewswire | Image: MediCircle

The post Regeneron Reports Results of REGN-COV2 in P-ll/lll Study in Patients with COVID-19 in Outpatient Setting first appeared on PharmaShots.

Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE)

Shots:

  • Part A of P-lll study involves assessing of Dupixent (qw, 300mg) vs PBO in 81 patients aged≥ 12 yrs. with EoE. The study resulted in meeting its co-primary and all key 2EPs, presented at the virtual ACG 2020 and UEG Week 2020
  • Results: Patients reported significant improvement on DSQ as 4 wks. and continued to improve through 24 wks; reduced EEC (<15) eos/hpf (64% vs 8%) @24wks. Peak EEC (71% vs 3%). ET changes associated with the disease reduced (0.761 and 0.753 vs 0.001 and 0.012) reduction @24wks.; gene expression patterns associated with type 2 inflammation and EoE were reduced (1.97-fold & 2.66-fold vs 0.32-fold & 0.16-fold); SAEs (86% vs 82%)
  • Dupixent is mAb inhibiting the signaling of the IL-4 and IL-13 proteins and has received the US FDA’s BT designation for the treatment of patients ≥12yrs. with EoE

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Chemistry World

The post Sanofi and Regeneron Report Results of Dupixent (dupilumab) in Part A of P-lll Study for Eosinophilic Esophagitis (EoE) first appeared on PharmaShots.

PharmaShots Weekly Snapshot (Oct 12-16, 2020)

Novartis’s Luxturna (voretigene neparvovec) Receives Health Canada Approval as the First Gene Replacement Therapy for Inherited Retinal Disease

Published: Oct 15, 2020 | Tags: approval, Canada, health, Inherited Retinal Disease, Luxturna, Novartis, receives, voretigene neparvovec

Galapagos & Servier’s GLPG1972/S201086 Fails to Meet its Primary Endpoint in P-II ROCCELLA Study for Knee Osteoarthritis

Published: Oct 15, 2020 | Tags: Clinical, Trial, Galapagos, GLPG1972/S201086, Knee Osteoarthritis, Patients, P-II, Report, results, ROCCELLA, Servier

Sanofi and Translate Bio to Advance MRT5500 into Clinical Study Against COVID-19

Published: Oct 15, 2020 | Tags: advance, Against, Clinical, Study, COVID-19, MRT5500, Sanofi, Translate, Bio

Chugai Reports NDA Submission of Risdiplam to the MHLW as the First Oral Drug for SMA in Japan

Published: Oct 15, 2020 | Tags: Chugai, Drug, First, Japan, MHLW, NDA, Oral, Report, Risdiplam, Spinal Muscular Atrophy

Merck’s Keytruda (pembrolizumab) Receives the US FDA’s Approval for Relapsed or Refractory Classical Hodgkin Lymphoma

Published: Oct 15, 2020 | Tags: Adult, approval, KEYTRUDA, Merck, patients, pembrolizumab, receives, Relapsed Refractory cHL, US, FDA

Eli Lily to Acquire Disarm Therapeutics for ~$1.36B

Published: Oct 15, 2020 | Tags: ~$1.36B, Acquire, Disarm, Therapeutics, Eli Lily

Eli Lilly Pauses Enrollment in ACTIV-3 Clinical Trial Due to Safety Concerns

Published: Oct 14, 2020 | Tags: ACTIV-3, Clinical, Decision, Due, Eli Lilly, Enrollment, NIAID, Pause, Trial

Sorrento to Initiate P-II Study of STI-5656 (abivertinib maleate) for COVID-19 in Brazil

Published: Oct 14, 2020 | Tags: Abivertinib Maleate, ANVISA, approval, COVID-19, Mild, P-II, patients, Proceed, receives, Severe, Sorrento, STI-5656, Trial

Bayer Report Results of Aliqopa (copanlisib) + Rituximab in P-III CHRONOS-3 Study for Relapsed Indolent Non-Hodgkin’s Lymphoma

Published: Oct 14, 2020 | Tags: 1EP, Aliqopa, Bayer, copanlisib, Meets, patients, reports, results, Rituximab

Takeda Collaborates with Accenture and AWS to Transform into a Cloud-Based Company

Published: Oct 13, 2020 | Tags: Accenture, AWS, Cloud-Based Company, Collaborates, Takeda, Transform

Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Published: Oct 15, 2020 | Tags: approval, atoltivimab, Ebolavirus, First, Inmazeb, maftivimab, odesivimab, receives, Regeneron, Treatment, US, FDA

Roche Signs a License Agreement with Dyno to Develop AVV Gene Therapy for ~$1.8B

Published: Oct 14, 2020 | Tags: ~$1.8B, AVV, Gene, Therapy, Develop, Dyno, License, Agreement, Roche, Signs

Boehringer Ingelheim Presents Results of Gilotrif (afatinib) for NSCLC at IASLC NACLC 2020

Published: Oct 14, 2020 | Tags: 2020, Boehringer Ingelheim, Gilotrif, IASLC, NACLC, Report, Result

Moderna Initiates Rolling Submission to Health Canada for mRNA-1273 Against COVID-19  

Published: Oct 14, 2020 | Tags: COVID-19, Health Canada, Moderna, mRNA Vaccine, mRNA-1273, Rolling Submission

Prestige’s PBP1510 Receives EMA’s Positive Opinion on Orphan Designation for Pancreatic Cancer

Published: Oct 14, 2020 | Tags: Designation, EMA, Opinion, Orphan, Pancreatic cancer, PBP1510, Positive, Prestige, receives

Celltrion Launch P-III Post-Exposure Prophylaxis Clinical Trial of CT-P59 for COVID-19

Published: Oct 14, 2020 | Tags: Anti, Candidate, Celltrion, Clinical Trial, COVID-19, CT-P59, Launch, mAb, P-III, Treatment

Linnaeus Reports First Patients Dosing with LNS8801 + Keytruda (pembrolizumab) in P-I/II Study for Advanced Cancer

Published: Oct 14,2020 | Tags: Advanced Cancer, First Patients Dosing, KEYTRUDA, Linnaeus, LNS8801, pembrolizumab, reports

J&J Pauses Dosing in COVID-19 Vaccine Studies Due to Unexplained Illness

Published: Oct 14, 2020 | Tags: COVID-19, Dosing, J&J, Pauses, Unexplained Illness, Vaccine, Studies

Roche to Launch Elecsys SARS-CoV-2 Antigen Test for Suspected COVID-19 Patients

Published: Oct 13, 2020 | Tags: Antigen, COVID-19, Laboratory, Launch, patients, Roche, SARS-CoV-2, Suspected, Test

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA VOYAGE Study in Children with Asthma

Published: Oct 13, 2020 | Tags: Asthma, attacks, Biologic, Children, children’s, Demonstrate, dupilumab, Dupixent, Function, Improvement, Lung, P-III Trial, Reduced, reports, results, Sanofi, Severe

Gilead and Galapagos Report Results of Filgotinib in P-llb/lll SELECTION Study for Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Filgotinib, Galapagos, Gilead, P-2B/3, reports, results, SELECTION Study, Ulcerative Colitis (UC)

Lilly Reports Results of Mirikizumab in P-ll SERENITY Study for Crohn’s Disease

Published: Oct 13, 2020 | Tags: Crohn Disease, Improvement and Reduction of Intestinal Inflammation, Lilly, Mirikizumab, P-ll, reports, results, SERENITY Study

Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from VISIBLE OLE Study for Moderately to Severely Active Ulcerative Colitis

Published: Oct 13, 2020 | Tags: Active, During, Entyvio, Long-Term, Maintenance, Moderately, reports, results, Severely, Takeda, therapy, Vedolizumab

Abbott’s AdviseDx SARS-CoV-2 IgM Test Receives the US FDA’s EUA for COVID-19

Published: Oct 13, 2020 | Tags: Abbott, antibody, Authorization, Blood, Test, COVID-19, Emergency, IgM, New, receives, Test, U.S.FDA, Use

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 12, 2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA Granted Marketing Approval, Rituximab

Janssen Reports Five-Year Data of Stelara (ustekinumab) in P-lll LTE Study for Severe Crohn’s Disease

Published: Oct 12, 2020 | Tags: Five-Year, Janssen Pharmaceutical, LTE Study, P-lll, Report, results, Severe Crohn’s Disease, Stelara, ustekinumab

AstraZeneca Advances its AZD7442 in Two P-III Clinical Studies for COVID-19

Published: Oct 12,2020 | Tags: Acting, antibody, AstraZeneca, AZD7442, COVID-19, Long, P-III, Test, Treatment, Trials

Janssen Reports Results of Tremfya (guselkumab) in Interim Analysis of P-II GALAXI 1 Study for Moderately to Severely Active Crohn’s Disease

Published: Oct 12,2020 | Tags: Active Crohn’s Disease, guselkumab, Interim, Janssen, P-II, patients, reports, Result, study, Tremfya

Pfizer’s Ibrance (palbociclib) Fails to Meet its Primary Endpoint in P-lll PENELOPE-B Study for Early Breast Cancer

Published: Oct 12,2020 | Tags: Breast Cancer, German Breast Group, Ibrance, P-lll, Palbociclib, PENELOPE-B Study, Pfizer Inc., Report, results

Innovent and Lilly’s Halpryza (biosimilar, rituximab) Receive NMPA’s Approval in China

Published: Oct 10,2020 | Tags: Autoimmune Disease, Halpryza, Innovent, Lilly, NMPA, Granted, Marketing Approval, Rituximab

Related Post: PharmaShots Weekly Snapshot (Oct 5-9, 2020)

The post PharmaShots Weekly Snapshot (Oct 12-16, 2020) first appeared on PharmaShots.

Regeneron’s antibody cocktail approved by FDA for Ebola

An antibody cocktail from Regeneron has been approved by the FDA as the first treatment for Ebola, offering hope that a similar approach could be used to combat COVID-19.

The FDA approved Inmazeb (atoltivimab, maftivimab and odesivimab-ebgn) for treatment of infection caused by Zaire ebolavirus in adults and children including newborns of mothers who test positive for the infection.

Approval was based on a large clinical trial where Inmazeb showed superiority compared with other investigational agents with respect to mortality, with treatment most effective when given early in the disease.

The therapy is based on a triple cocktail of monoclonal antibodies. Regeneron is using the same technology to develop the COVID-19 antibody combination famously given to president Donald Trump.

Regeneron has an agreement with the Biomedical Advanced Research and Development Authority (BARDA), a US government agency, to deliver an undisclosed number of doses of the drug over the course of six years after approval.

The New York- based company expects to receive around $10 million in 2021 under the deal signed earlier this year, and an average of $67 million per year for the next five years.

The drug has also been developed with funding from BARDA

In 2019, Regeneron’s randomised controlled PALM clinical trial was stopped prematurely when preliminary results showed that REGN-EB3 crossed the pre-specified superiority threshold for preventing death compared to the control arm.

Those in the control arm were treated with Mapp’s ZMapp, a rival cocktail of monoclonal antibodies.

Regeneron noted that its cocktail, codenamed REGN-EB3, outperformed ZMapp across several measures in the trial, including reduced mortality and fewer days until the Ebola virus was no longer detected in the bloodstream.

The trial involved nearly 700 patients and had three serious adverse events for REGN-EB3 compared with seven for ZMapp.

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Regeneron’s Inmazeb (atoltivimab, maftivimab, and odesivimab) Receives the US FDA’s Approval as the First Treatment for Ebola

Shots:

  • The approval is based on the PALM trial assessing Inmazeb vs Zmapp and remdesivir in 681 adult and pediatric patients including newborns of mothers who have tested positive for the infection. The study demonstrated 1EPs of mortality @28days (33.5% vs 51.3%) and 2EPs of reduction in days until the virus was undetectable in the bloodstream
  • As per the agreement signed in Jul’2020, Regeneron will deliver a number of Inmazeb treatment doses for 6yrs. to the BARDA.
  • Inmazeb is a triple antibody cocktail consisting of 3 mAbs (atoltivimab, maftivimab & odesivimab, 50 mg each /kg) that bind to different, non-overlapping epitopes on Zaire ebolavirus glycoprotein

    Click here to­ read the full press release/ article | Ref: PR Newswire | Image: Stat

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Regeneron Seeks the US FDA’s EUA for REGN-COV2 Antibody Combination to Treat COVID-19

Shots:

  • Regeneron has submitted a request to the US FDA seeking EUA for its REGN-COV2 investigational Ab regimen to treat COVID-19. If EUA is granted, the US govt. has committed to making REGN-COV2 available in the US at no cost and would be responsible for its distribution
  • The company reported that there are doses available for ~50,000 patients and expects to have doses available for 300,000 patients in total within the next few months
  • REGN-COV2 is a combination of two mAbs, REGN10933 & REGN10987, designed to block the infectivity of SARS-CoV-2. The company reported that a single 8g dose of REGN-COV2 was given to President Donald Trump following a compassionate-use request from doctors as part of a treatment regimen

    Click here ­to­ read full press release/ article | Ref: Eyewire | Image: Times Union

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Regeneron joins Lilly in seeking emergency OK for COVID-19 antibody

Regeneron has followed Eli Lilly in asking the FDA for emergency approval of its COVID-19 antibody therapy, shortly after the drug was thrust into the spotlight by being used to treat President Trump.

The request for emergency use authorization (EUA) for REGN-COV2 comes amid a spike in interest about antibodies against the SARS-CoV-2 coronavirus, driven by Trump’s assertions that the drug was instrumental in his apparently swift recovery from the infection and is a “cure” for COVID-19.

That rise in demand is however already forcing a reality check about how many patients may be able to get REGN-COV2 treatment. In its statement on the EUA request, Regeneron says it has supplies available to treat 50,000 patients, adding that should rise to 300,000 “within the next few months.”

That’s far from what will be needed, points out former FDA Commissioner Scott Gottlieb in a tweet suggesting demand could be more than 7,500 patients per day.

The US has had more than 7.5 million cases of COVID-19 and 213,000 deaths to date, with around 50,000 new cases every day.

Regeneron has been working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, and recently enlisted the aid of Roche to expand capacity. The US has rights to the first 300,000 doses under that funding agreement.

Shares in Regeneron continued their inexorable rise on the news, with another surge after Trump’s comments, and the stock is now trading at twice their value from a year ago at close to $600.

The cocktail of two antibodies targets two components in the spike protein on SARS-CoV-2 with the aim of preventing attachment of the virus to host cells and interrupting infection.

The clinical data behind the EUA comes from a study in 275 patients, and looks promising. The latest readout from the trial showed the drug reduced both viral load and the time to alleviation of symptoms in non-hospitalised patients with COVID-19.

The greatest benefit was seen in patients who had not mounted their own immune response against the virus, according to trial investigators. Results in hospitalised COVID-19 patients are due later this year, and the antibody drug is also being tested for prophylaxis of SARS-CoV-2 infection.

There are still plenty of dissenting voices about REGN-COV2 however, suggesting that it’s far too early to make a judgment on how well it works.

One US physician pointed out that Trump was also treated with dexamethasone – a potent steroid shown clinically to improve survival in COVID-19 – that can make patients feel “20 years younger” – an effect reported by Trump.

The President was also treated with Gilead Sciences’ Veklury (remdesivir) – also shown to reduce the duration of symptoms in trials – as well as various other remedies including zinc and vitamin D supplements, the heartburn drug famotidine, melatonin and aspirin.

Regeneron’s request came hard on the heels of Lilly’s EUA filing for its antibody cocktail LY-CoV555 for use in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19. The company has said it could be able to produce up to a million doses of the drug.

Meanwhile, other companies including AstraZeneca and GlaxoSmithKline/Vir are also working on antibody-based therapies for the disease. It’s clear however that if approved, these drugs will have to be used thoughtfully and sparingly to eke out limited supplies.

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Lilly asks FDA for emergency clearance for COVID-19 antibody therapy

Eli Lilly has asked the FDA for an Emergency Use Authorization for its COVID-19 antibody therapy, after announcing new efficacy data from an ongoing trial.

It’s been a big week for this class of therapies – Regeneron’s antibody cocktail was famously used to treat president Donald Trump’s illness and GlaxoSmithKline is expanding research into its rival.

The big US pharma is asking for an emergency approval of the monotherapy version of its antibody therapy codenamed LY-CoV555.

The Emergency Use Authorization (EUA) will be for use in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.

This is expected to be followed by an EUA in November for the combination therapy, if more patients enrol on trials, further data on safety is available and enough stock has been manufactured.

Lilly announced data from an interim analysis of the BLAZE-1 clinical trial that showed the combination of two of Lilly’s virus-neutralising antibodies reduced viral load, symptoms, COVID-related hospitalisation, and emergency room visits.

The randomised, double-blind, placebo-controlled phase 2 study tested LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting.

The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, with 112 patients receiving 2800 mg of each antibody, with 156 receiving placebo.

The combination therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study.

An exploratory analysis showed that the proportion of patients with persistent high viral load at day seven for combination therapy was 3% versus 20.8% on placebo – a highly statistically significant finding.

So far no resistant viral strains have emerged in patients treated with the combination therapy, the company added.

Other endpoints met included improvements in symptom score, and this was observed as early as three days after dosing and was similar in magnitude to monotherapy with LY-CoV555.

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GSK and Vir expand COVID-19 antibody trial after Trump’s treatment with Regeneron’s rival

GlaxoSmithKline and partner Vir Biotechnology are to expand a trial of an experimental antibody to treat COVID-19, putting heat on Regeneron’s rival that has been famously used to treat president Donald Trump.

GSK and Vir began trials of the antibody on early-stage COVID-19 patients in August, with the aim of preventing symptoms from progressing.

The antibody in question, VIR-7831 has already been shown to neutralise the SARS-CoV-2 live virus in the lab and in animals.

It also works against a target found on the SARS-CoV-1 coronavirus that causes SARS, and the companies hope that it will be more resistant to any mutations in the virus that causes COVID-19 over time.

An Independent Data Monitoring Committee recommended at the end of September that the trial should move into phase 3 based on a positive evaluation of safety and tolerability data from the phase 2 section of the COMET-ICE trial.

The phase 3 portion of the trial will test safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in around 1,300 non-hospitalised patients, split equally between the placebo and treatment arms.

The primary efficacy endpoint is the proportion of patients who have progression of COVID-19 as defined by the need for hospitalisation or death within 29 days of randomisation.

Results from interim analyses may be available as early as the end of the year, with the primary endpoint readout expected in January 2021 or some time within the first quarter.

The COMET clinical development programme for VIR-7831 includes two additional trials – one for the treatment of hospitalised patients and another for the prevention of symptomatic infection.

Antibody treatments for COVID-19 are currently in the spotlight after it emerged that president Donald Trump received treatment with a rival cocktail from Regeneron.

The Regeneron therapy is still experimental and unproven in the clinic and is based on a cocktail of two antibodies that neutralise the virus.

Shares in Regeneron were surging earlier in the week after it emerged that Trump had received the therapy known as REGN-COV2.

Questions were also raised about Trump’s links with Regeneron – CNN cited filings with the US Office of Government Ethics showing the president had invested in Regeneron and rival Gilead in 2017, although the companies were not listed in his 2020 declaration.

Regeneron CEO Dr Leonard Schleifer is a member at Trump’s golf club in Westchester, New York and the company also received $450 million in government funding in July as part of the president’s Operation Warp Speed plan to quickly develop a vaccine and other treatments for COVID-19.

Feature image courtesy of NIH/Rocky Mountain Laboratories

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PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020)

  1. Sobi & Selecta Report Results of SEL-212 in P-II COMPARE Study for Chronic Refractory Gout

Published: Oct 1, 2020 | Tags: Chronic Refractory Gout, COMPARE Study, Important Clinical Improvement, P-II, patients, reports, results, SEL-212, Selecta Biosciences, Sobi

2. Moderna’s mRNA-1273 COVID-19 Vaccine Demonstrate Immune Responses in Older Adults

Published: Oct 1, 2020 | Tags: COVID-19, Moderna, mRNA-1273, P-l study

3. Alnylam Reports Results of Lumasiran in P-III ILLUMINATE-B Study for Primary Hyperoxaluria Type 1 in Children Under the Age of Six

Published: Oct 1, 2020 | Tags:  Alnylam, ILLUMINATE-B, Lumasiran, P-III study, Primary Hyperoxaluria Type 1, reports, results

4. Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Published: Oct 1, 2020 | Tags: Janssen, NDA, Pulmonary Arterial Hypertension, reports, selexipag, Submission, Treat, UPTRAVI, USFDA

5. Henlius Signs an Exclusive License Agreement with Accord for HLX02 (biosimilar, trastuzumab) in the US and Canada

Published: Oct 1, 2020 | Tags: Accord Healthcare Inc., Develop and Commercialize, Exclusive License Agreement, Henlius, HLX02

6.  Sanofi Launches Tetraxim (DTaP-IPV) for Preschoolers in India

Published: Oct 1, 2020 | Tags: (DTaP-IPV), India, Launches, Preschoolers, Sanofi, Tetraxim

7. Abbott’s FreeStyle Libre 3 System Receives CE Mark in Europe

Published: Sept 30, 2020 | Tags: Abbott, CE Mark, Europe, FreeStyle Libre 3 System, receives

8. Medtronic to Acquire Avenu Medical

Published: Sept 30, 2020 | Tags: Acquire, Avenu Medical, Ellipsys Vascular Access system, endovascular solutions, Medtronic

9. BMS’s Reblozyl (luspatercept) Receives Health Canada Approval for Beta Thalassemia

Published: Sept 30, 2020 | Tags: Beta Thalassemia, BMS, Health Canada Approval, Luspatercept, Reblozyl

10. Junshi Reports Results of Dual Regimen in P-III Jupiter-02 Study as 1L Therapy for Nasopharyngeal Carcinoma

Published: Sept 30, 2020 | Tags: 1L Therapy, Dual Regimen, Junshi Biosciences, Jupiter-02 Study, Nasopharyngeal Carcinoma (NPC), P-lll

11. Galapagos Reports First Patients Dosing with GLPG3970 (Toledo Compound) for Psoriasis

Published: Sept 30, 2020 | Tags: First Patients Dosing, Galapagos, GLPG3970, LADYBUG study, ll CALOSOMA study, P-l/ll, Psoriasis, SEA TURTLE study

12. Regeneron’s REGN-COV2 Demonstrate Reduction in Viral Load and Improve Symptoms in Non-Hospitalized Patients with COVID-19

Published: Sept 30, 2020 | Tags: COVID-19, Demonstrate, Improve Symptoms, Non-Hospitalized, patients, Reduction, Regeneron, REGN-COV2, Viral Load

13. Boston Scientific Launches ACURATE neo2 Aortic Valve System in Europe

Published: Sept 29, 2020 | Tags: ACURATE neo2 Aortic Valve System, Boston Scientific Corporation, Europe, Launches

14. Inovio Reports FDA’s Partial Clinical Hold on P-II/III Trial of INO-4800 Against COVID-19

Published: Sept 29, 2020 | Tags: COVID-19, FDA’s, INO-4800, Inovio, P-ll/lll Study

15. CSL Behring’s Haegarda (C1 Esterase Inhibitor) Receives the US FDA’s Approval for Pediatric Patients with Hereditary Angioedema

Published: Sept 29, 2020 | Tags: CSL behring, HAE, Haegarda, Hereditary Angioedema, Pediatric Patients, US FDA’s Approval

16. Pfizer’s Xeljanz (tofacitinib) Receives the US FDA’s Approval for Active Polyarticular Course Juvenile Idiopathic Arthritis

Published: Sept 29, 2020 | Tags: Active Polyarticular Course Juvenile Idiopathic Arthritis, approval, FDA, receives, tofacitinib, US, XELJANZ

17. AbbVie’s Elezanumab (ABT-555) Receives the US FDA’s Orphan Drug and Fast Track Designation for Spinal Cord Injury

Published: Sept 29, 2020 | Tags: AbbVie, Elezanumab, FDA, FT, ODD, Spinal Cord Injury, US

18. Sarepta Reports Two-Year Follow Up Results of SRP-9001 for Duchenne Muscular Dystrophy

Published: Sept 29, 2020 | Tags: Duchenne Muscular Dystrophy, reports, results, Sarepta, SRP-9001, Two-Year Follow Up

19. Innovent Report Results of Dual Regimen in P-III ORIENT-32 Study as 1L Therapy for Advanced HCC

Published: Sept 28, 2020 | Tags: 1L Therapy, Byvasda, Hepatocellular Carcinoma (HCC), Innovent Biologics, Tyvyt

20. Pfizer Initiates Clinical Study of Eighth Candidate Emerges Under the Collaboration with Sosei Heptares

Published: Sept 28, 2020 | Tags: Candidate, Clinical Study, Collaboration, Emerges, Initiates, Pfizer, Sosei Heptares, Under

21. Roche Reports Two-Year Data for Evrysdi (risdiplam) in Infants with Type 1 SMA

Published: Sept 28, 2020 | Tags: (risdiplam), Data, Evrysdi, Infants, reports, Roche, Two-Year, Type 1 SMA

22. GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as the First Treatment for Hypereosinophilic Syndrome

Published: Sept 28, 2020 | Tags: (mepolizumab), approval, FDA, GSK, Hypereosinophilic Syndrome, Nucala, receives, US

23. Chugai’s Tecentriq (atezolizumab) and Avastin (bevacizumab) Receive MHLW’s Approval as 1L Treatment for Unresectable Hepatocellular Carcinoma

Published: Sept 28, 2020 | Tags: (atezolizumab), (bevacizumab), 1L, approval, Avastin, Chugai, MHLW, Receive, Tecentriq, Treatment, Unresectable Hepatocellular Carcinoma

24. Gilead’s Jyseleca (filgotinib) Receives the MHLW’s Approval for Rheumatoid Arthritis in Japan

Published: Sept 28, 2020 | Tags: Filgotinib, Gilead, JAK1 Inhibitor, Jyseleca, MHLW Approval, Rheumatoid Arthritis, Structural Joint Damage

The post PharmaShots Weekly Snapshot (Sept 28 – Oct 1, 2020) first appeared on PharmaShots.

Is COVID the Rx for the Pharmaceutical Industry’s Reputation?

Darlene Dobry, Pharmaceutical Marketing

Darlene Dobry, Strategic Advisor, Medical Devices and Pharmaceuticals

As the COVID-19 pandemic continues to bring the world’s economies, healthcare systems, and communities to their knees, the Pharma industry appears to be the shining hope to help us return to a new normal. Could the industry’s response to this global public health crisis be the Rx for its tarnished reputation?

The Pharma industry has long been at the center of a firestorm, cited consistently as one of the most disliked and distrusted industries in the Gallup poll. It’s not surprising given the media coverage of CEO and company financial disclosures, patent trials, illegal activities, and questionable practices, legal settlements, price gouging, product recalls, and, most recently, its role in the devastating opioid epidemic. While the public’s high distrust and disdain are directed at “greedy” Pharma, prescription drug spending accounts for between 10-12% of total US healthcare costs, and now, in our time of greatest need, we turn to this industry to help us confront COVID-19. This pandemic has brought the committed, community-focused side of Pharma to the forefront, with its rapid and relentless pursuit to deliver the best science to solve this crisis.

Pharmaceuticals Collaborating for COVID’s Rx

There are brilliant and talented people in dozens of companies, both established manufacturers and small start-ups, working tirelessly to find a solution. Early efforts developed and produced testing assays to help the healthcare community identify and confirm the virus. The expanded focus now pursues proven treatments and vaccines. We see unexpected partnerships and creativity abound in the race to find answers that will address the crippling impact on public health and disrupt the economy and supply chains. Thomas Cueni, who leads the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, notes, “the industry, which is traditionally fiercely competitive, has come together.”

For example, rivals like Sanofi and GSK are working to bring their innovative technologies together for a vaccine, with Astra-Zeneca and Oxford University signing a global development and distribution agreement for a CO-19 vaccine, Takeda and CoVIg-19 Alliance investing in plasma therapies, Regeneron and Sanofi conducting clinical trials for their jointly marketed Rheumatoid Arthritis drug Kevzara, and Pfizer and BioNTech are collaborating on an mRNA vaccine. There is an impressive number of ongoing trials to evaluate existing drugs for other diseases, including Gilead’s Remdesivir which now has FDA authorization for emergency use, and Gilead Sciences is applying for full authorization in the U.S., specialty biotech companies like Moderna and Novavax have also entered the race and are fast-tracked for their vaccine candidates.

Pharma’s Investments & Innovations during COVID-19

Beyond drug treatment and vaccine development, the industry has also brought new ingenuity and investment to fight COVID-19 and support the healthcare system; Johnson & Johnson is pledging $300M over ten years to help front-line workers, Astra-Zeneca donating 9M face masks to protect healthcare workers around the world, companies deploying their 3D printing capabilities to manufacture PPE and equipment, and Consumer Product companies producing hand sanitizers.

This industry, its brilliant researchers, and dedicated employees are unwavering in their mission to be a part of the solution by investing in unknowns despite the risk, diverting focus from other commercially available/development assets, and pioneering scientific innovation to confront COVID-19. With the sheer number of companies in this race, we stand the best chance of finding solutions and having the scale to keep up with the alarming projections of cases. It also helps to foster competition and encourage fair pricing. Despite Pharma‘s commitment to the cause, there continue to be critics who attribute Pharma’s efforts to capitalizing on a crisis and solely focused on profit. For those who feel Pharma should not make a profit from the deep investment, at this moment, it’s difficult to put a price on overcoming this enemy.

Pharma Marcom & PR during COVID

With the knowledge that consumers look to brands and companies that demonstrate social responsibility, philanthropic and community support, other industry leaders and I agree that there is an opportunity for Pharma to begin to evolve from some of the negative perceptions and elevate recognition of its essential role in moving us from “StayatHome” to “StayHealthy.” We are beginning to see public opinion improve throughout this pandemic, according to a recent Harris poll. From a marketing and public relations standpoint, I’m hopeful the Pharmaceutical Research and Manufacturers of America (PhRMA) will take this moment to elevate public awareness and highlight the level of corporate commitment and investment behind the scenes of this pandemic.

This is not self-serving. This is about scientific innovation, leadership during crisis, corporate responsibility, and saving lives. The industry should continue to demonstrate its thought leadership during this time through scientific publications and serving as an expert voice. As consumers increasingly search for information about the virus, vaccines, and treatment, Pharma needs to ensure the public has access to credible, scientifically-grounded content across media channels. Given the sequelae from this pandemic, there is also a tremendous need to address mental health and wellbeing. With the significant investment and access to mental health solutions and services, Pharma can also answer this call.

Pharma Marketing & Healthcare Marketing | COVID & Beyond

As advertising and communication experts, now is the time to step up and be even truer and more innovative pharmaceutical marketing agency partners. While our pharma, medical and healthcare clients are redirecting their efforts toward COVID-19, our own industry must be even more proactive and creative. Let’s bring pharmaceuticals strategically inventive marketing communication ideas and messaging programs to keep their brands and marketing more relevant during the COVID pandemic. Let’s help pharmas more effectively reach their increasingly “remote” customers and patients. Let’s drive better search rankings by developing more useful and authoritative content to educate online-engaged healthcare audiences. Let’s explore corporate campaigns and grass-roots programs to draw medical and pharmaceutical enterprises closer to their patient communities and genuinely bolster reputations. As experts in social media, let’s help Pharma be consistently compliant and proactively trustworthy participants in conversations concerning diseases & conditions. Let’s elevate the pharma industry’s core values currently on display through successfully inventive creativity and discerning innovation. As partners, let’s work tirelessly to create and focus insightful spotlights on the heroic efforts of our client-partners — healthcare and medical innovators dedicated to making “life-changing” differences within today’s life-changing public health crisis.

COVID and Healthcare Marketing — related articles: [Podcast] Hospital Crisis Management and Healthcare PR in the Age of COVID-19 | 5 Ways You Can Use Social Media and Digital Marketing to Help the Public During the COVID-19 Pandemic | Healthcare Marketing: Pause, Pivot, or Push for Success?

 

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Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2

Roche has agreed to help Regeneron manufacture its COVID-19 antibody cocktail REGN-COV2, which started late-stage clinical testing a few weeks ago, in a deal that could more than triple supplies of the drug if it gets approved.

Regeneron is already working on ramping up manufacturing capacity for REGN-COV2, with the help of $450 million in funding from the US government, but has admitted that it won’t be able to meet the expected demand for the drug on its own.

The agreement with Roche will “substantially” increase the number of doses available if the drug works in clinical trials.

REGN-COV2 was the first therapeutic to be backed under the Trump administration’s Operation Warp Speed, which previously had focused only on coronavirus vaccines.

It is being tested in phase 2/3 trials both as a treatment for coronavirus infections as well as prophylaxis against infection in people exposed to SARS-CoV-2, with initial results expected before the end of September.

The US deal envisaged 70,000 to 300,000 therapeutic doses of the drug being made available by September, equivalent to 420,000 to 1.3 million prevention doses.

Under the terms of the agreement, each company has committed to dedicate a portion of its production capacity to REGN-COV2 each year.

The two partners think that by working together they could increase capacity to provide up to 2 million therapeutic or 8 million prophylactic courses a year.

Meanwhile, in addition to chipping in for its production, Roche also gets distribution rights to the antibody cocktail outside the US, in return for jointly funding and carrying out the phase 3 stage of the prevention trial as well as phase 1 healthy volunteer safety studies outside the US.

The Swiss drugmaker will also take responsibility for filing REGN-COV2 outside the US and carrying out any trials needed in those countries. Profits from the drug will be split, with Regeneron’s share expected to be in the 50% to 60% range.

REGN-COV2 was developed by Regeneron based on tests in mice genetically modified to have a human immune system, as well as antibodies isolated from humans who have recovered from COVID-19.

The cocktail targets two components in the spike protein on SARS-CoV-2, the virus that causes COVID-19, with the aim of preventing attachment of the virus to host cells and interrupting infection.

The same approach has been used in the development of Regeneron’s Ebola candidate REGN-EB3, which is under review at the FDA with a verdict due in October.

The post Regeneron recruits Roche to make COVID-19 antibody drug REGN-COV2 appeared first on .

Regeneron Collaborates with Roche to Improve the Global Supply of REGN-COV2 Against COVID-19

Shots:

  • The two global companies collaborated to develop, manufacture, and distribute REGN-COV2 across the globe. The agreement is expected to increase the supply of REGN-COV2 to at least 3.5 times the current capacity with the potential for expanding it further
  • Regeneron will lead the distribution in the US while Roche will be responsible for the distribution outside the US, both will bear distribution expenses in their designated territories. Each partner will dedicate a manufacturing capacity to REGN-COV2 every year while the collaborators have started the technology transfer process
  • The partners will jointly fund and execute the ongoing P-III prevention and P-I healthy volunteers safety studies as well as additional global studies to assess the potential for REGN-COV2 against COVID-19. Additionally, Roche will solely responsible for the initial EMA’s approval or conducting any additional studies required for approval outside the US

Click here ­to­ read full press release/ article | Ref: Roche| Image: StraitTimes

Regeneron’s cholesterol drug evinacumab claims February FDA date

The FDA has started a speedy review of Regeneron’s ANGPTL3-targeting antibody evinacumab for a rare, inherited disorder that dramatically raises the risk of heart disease.

The cholesterol-lowering drug has been classed as a breakthrough therapy for homozygous familial hypercholesterolaemia (HoFH) by the FDA, which is due to deliver a decision on the marketing application by 11 February after a truncated six-month review.

HoFH affects around 1,300 people in the US, says the biotech, and raises cholesterol levels in the blood to very high levels. As a consequence, people with the condition can develop cardiovascular disease very early, even in childhood in some cases, despite aggressive treatment with cholesterol-lowering drugs like statins and PCSK9 inhibitors.

Evinacumab (formerly REGN1500) was developed after scientists discovered that people with genetic profiles that reduced ANGPTL3 gene activity had significant lower levels of LDL cholesterol, and a decrease in the risk of developing heart disease,

If approved, it will sit alongside Sanofi-partnered PCSK9 inhibitor Praluent (alirocumab) – which has underperformed since its launch in 2015 – in Regeneron’s emerging cardiovascular franchise.

The ANGPTL3 antibody has been filed for approval in the US and Europe on the back of the phase 3 ELIPSE trial, which tested the antibody in 65 HoFH patients already being treated with statins, PCSK9 inhibitors and other drugs like ezetimibe.

Adding in Regeneron’s antibody resulted in a 49% drop in cholesterol levels from the start of the study compared to patients sticking with their current therapy alone, according to results presented earlier this year at the American College of Cardiology’ congress in March.

The FDA awarded evinacumab breakthrough status in 2017 on the strength of phase 2 data which also showed that the antibody could achieve impressive 50% reductions in LDL cholesterol, as well as cutting blood lipids like triglycerides, in HoFH patients.

There’s no data showing that the drug can reduce progression to heart disease yet, but it’s widely believed that cutting blood lipids can reduce that risk.

Not all patients with HoFH are the same however as there are multiple genes involved in the disease, including those for LDL receptors, apolipoprotein B and PCSK9.

Crucially, Regeneron’s drug seems to work even in so-called ‘null-null’ patients, which have very low levels of receptors that remove LDL cholesterol from the blood and so progress to cardiovascular complications very quickly.

Evinacumab may not be so significant commercially however, at least in the near term, although it will likely be able to command higher pricing than Praluent due to the rarity of HoFH. Analysts put peak US sales in the region of $200 million to $400 million.

Once tipped as blockbusters, Praluent and a rival PCSK9 drug from Amgen – Repatha (evolocumab) – have struggled to gain sales momentum in the much larger population of people with other forms of high cholesterol, and have yet to crack the $1 billion sales threshold, even when their sales are combined.

They now also face the threat of competition from Novartis PCSK9 rival inclisiran, which offers much less frequent dosing.

Evinacumab is expected to be a smaller product, thanks to the tiny population affected by the ultra-rare indication, although Regeneron will be able to detail using the same salesforce that sells Praluent, reducing the cost of rollout if approved.

The biotech is also running trials that could end up expanding its use into patients with heterozygous familial hypercholesterolaemia (HeFH) – a less severe inherited disorder – as well as for patients with non-inherited forms of high cholesterol who can’t meet treatment targets with a statin and PCSK9 inhibitor.

The post Regeneron’s cholesterol drug evinacumab claims February FDA date appeared first on .

Regeneron Reports the US FDA’s Acceptance of Evinacumab’s BLA for Priority Review as a Treatment for Patients with HoFH

Shots:

  • The BLA is based on P-III study evaluating the efficacy and safety of evinacumab (15 mg/kg, IV, q4w) in 65 patients aged ≥12yrs. with HoFH. The 1EPs of the study is reduction of LDL-C from baseline
  • The expected PDUFA date for the therapy as Feb 11, 2021. The US FDA has granted BT designation to the therapy for the treatment of hypercholesterolemia in patients with HoFH in 2017
  • Evinacumab is an investigational mAb that binds to and blocks the function of ANGPTL3 and is currently being studied in patients with HoFH (ongoing P-III extension trial), refractory hypercholesterolemia (P-II) and severe hypertriglyceridemia (P-II)

Click here to­ read full press release/ article | Ref: Regeneron  | Image: CNN

Regeneron pairs with BioNTech on melanoma immunotherapy

Regeneron and Sanofi’s PD-1 inhibitor Libtayo will be tested in tandem with a cancer vaccine developed by BioNTech in melanoma in people who have failed treatment with other checkpoint inhibitors.

The two companies will carry out a phase 2 trial of Libtayo (cemiplimab) alongside BioNTech’s mRNA cancer immunotherapy BNT111, which is designed to stimulate immune responses against four cancer-related antigens: NY-ESO-1, MAGE-A3, tyrosinase, and TPTE.

The recruitment of BioNTech as a partner in melanoma comes after Regeneron and Sanofi decided to abandon development of Libtayo with their recently-approved anti-CD38 drug Sarclisa (isatuximab) in that indication.

Melanoma was the first cancer to be targeted by the checkpoint inhibitor class several years ago when Bristol-Myers Squibb’s Opdivo (nivolumab) and Merck & Co/MSD’s Keytruda (pembrolizumab) were both approved as second-line treatments for the disease within a few weeks of each other.

Since then, PD-1/PD-L1 inhibitors have moved into the first-line setting, and at the moment the combination of Opdivo and BMS’ CTLA4 inhibitor Yervoy (ipilimumab) – another immune checkpoint inhibitor – has become the go-to therapy for many oncologists.

The problem is that while 30% to 40% of melanoma patients get a long-lasting response to checkpoint inhibitor therapy, in the majority the drugs either don’t work at all or lose their potency over time allowing the cancer to come back.

Regeneron and BioNTech are hoping that adding BNT111 to anti-PD-1 therapy with Libtayo will overcome the resistance mechanisms that are present in some tumours, and increase the proportion of patients who respond to immunotherapy.

The phase 2 trial will recruit patients with advanced melanoma that can’t be treated with surgery who are refractory to or have relapsed after PD-1 drugs, and the costs of running it will be shared by the two partners. It is due to start before the end of the year.

“The combination of Libtayo and BNT111…has the potential to augment the immune system’s ability to effectively recognise melanoma in multiple ways and hopefully improve immune targeting to control the cancer,” commented Regeneron’s head of translational science and oncology Israel Lowy.

Libtayo was a late entrant into the PD-1/PD-L1 inhibitor market and while it has been able to carve out a small niche in cutaneous squamous cell carcinoma (CSCC), another form of skin cancer, it’s still a bit player.

Sanofi reported ex-US sales of €27 million ($32 million) for Libtayo in the first half of this year. Regeneron records US sales, but isn’t due to report its second quarter until later this week. It made just under $62 million from the drug in the first quarter.

The two partners are hoping to grow the drug with new indications such as basal cell carcinoma – another form of skin cancer – and non-small cell lung cancer (NSCLC), although they will face still competition in the latter from Merck’s market leader Keytruda.

Meanwhile, BNT111 is the lead candidate in BioNTech’s FixVacc cancer vaccines programme, which dominates its pipeline despite the recent close attention to the German biotech’s coronavirus candidate, partnered with Pfizer.

It is one of five FixVacc vaccines in early-stage clinical testing, along with candidates for prostate, head and neck,  ovarian and triple-negative breast cancer.

The post Regeneron pairs with BioNTech on melanoma immunotherapy appeared first on .

Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – July 2020

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected in Wuhan City, Hubei Province, China in Dec 2019. Life sciences companies are putting all of their efforts into finding a treatment or developing a vaccine for this disease. PharmaShots is keeping a track of all of the important updates in the Life-sciences sector, where we have covered news updates regarding collaborations, clinical trials, funding, and regulatory guidelines related to the COVID-19 from Jan to date.

75. Roche’s Actemra/RoActemra (tocilizumab) Fails to Meet the Primary Endpoint in P-III COVACTA Study for Patients with COVID-19 Associated Pneumonia

Jul 30, 2020 | Clinical Trial

74. Sanofi and GSK Sign an Agreement with the UK Government to Supply ~60M Doses of COVID-19 Vaccine

Jul 29, 2020 | Collaboration

73. UK’s Recovery Continues to Test Roche’s Tocilizumab in COVID-19

Jul 29, 2020 | Clinical Trial

72. Roche’s Actemra/RoActemra Fails in COVID-19 Trial

Jul 29, 2020 | Clinical Trial

71. Green Cross’ GC5131A Receives the Regulatory Approval for P-II Trial for COVID-19

Jul 29, 2020 | Regulatory

70. Relief’s RLF-100 (aviptadil) Receives the US FDA’s Expanded Access Protocol to Treat Respiratory Failure in COVID-19

Jul 29, 2020 | Regulatory

69. AstraZeneca Signs an Agreement with Emergent BioSolutions to Expand Manufacturing of AZD1222 for COVID-19  

Jul 28, 2020 | Regulatory

68. Pfizer and BioNTech Initiate P-II/III Global Study of its Lead mRNA Vaccine Candidate Against COVID-19

Jul 28, 2020 | Clinical Trial

67. Gilead’s Veklury (Remdesivir) Health Canada’s Marketing Authorization with Conditions (NOC/c) to Treat COVID-19 

Jul 28, 2020 | Regulatory

66. Three Pharma Companies Launch Favipiravir to Treat COVID-19 in India  

Jul 27, 2020 | Launch

65. Sorrento to Acquire SmartPharm and Develop Pipeline of Gene-Encoded Therapeutic Antibodies Targeting COVID-19 and Cancer  

Jul 27, 2020 | Collaboration

64. AI Therapeutics Reports Initiation of P-II Trial of LAM-002A (apilimod dimesylate) for COVID-19 Patients

Jul 27, 2020 | Clinical Trial

63. Zydus to Initiate Clinical Study of Desidustat in Patients with Chemotherapy-Induced Anemia (CIA)  

July 24, 2020 | Clinical Trial

62. Glenmark Report Results of FabiFlu (favipiravir) in P-III Clinical Study for Patients with Mild to Moderate COVID-19

Jul 27, 2020 | Clinical Trial

61. The UK Government to Launch AbC-19 Lateral Flow Free Finger-Prick Test for COVID-19  

Jul 27, 2020 | Launch

60. Mylan Launches Remdesivir Under the Brand Name Desrem for COVID-19 in India  

Jul 27, 2020 | Launch

59. Pfizer and BioNTech Elicits Strong T-cell Response in P-I/II Study Against COVID-19

Jul 27, 2020 | Clinical Trial

58. AstraZeneca and Oxford University’s AZD1222 Delivers Dual Immune Response in its P-II/III COV001 Study Against COVID-19

Jul 27, 2020 | Clinical Trial

57. Quest Diagnostic Receives the US FDA’s First EUA for Sample Pooling in COVID-19  

Jul 20, 2020 | Diagnostic

56. Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Jul 20, 2020 | Clinical Trial

55. Zydus Initiates Adaptive P-I/II Clinical Study Evaluating its ZyCoV-D Against COVID-19 in India  

Jul 16, 2020 | Clinical Trial

54. Novartis Launches Zero Profit Portfolio for Symptomatic Treatment of COVID-19

Jul 16, 2020 | Launch

53. AstraZeneca and the University of Oxford to Share Positive News on its COVID-19 Vaccine Imminently

Jul 15, 2020 | Collaboration

52. 3M Collaborates with MIT to Develop Paper-Based Diagnostic Test for COVID-19

Jul 13, 2020 | Collaboration

51. Moderna to Commence Late-stage COVID-19 Vaccine Trial on 27 July, 2020

Jul 13, 2020 | Clinical Trial

50. The International Fencing Federation (FIE) Reports the Global COVID-19 Support Plan

July 13, 2020 | Launch

49. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms  

Jul 12, 2020 | Regulatory

48. The Zimbabwe Government to Launch US $10M COVID-19 Relief Package

Jul 11, 2020 | Launch

47. Gilead’s Veklury (remdesivir) Receives the TGA’s Approval to Treat Adults and Adolescents with Severe COVID-19 Symptoms

Jul 10, 2020 | Regulatory

46. AstraZeneca Collaborates with ProteinQure to Design Novel Peptide Therapeutics

Jul 10, 2020 | Collaboration

45. Cipla Launches Cipremi at $53.34 per Vial in India

Jul 10, 2020 | Launch

44. The Health Ministry of Kyrgyzstan Reports Supply of Avifavir an Antiviral Drug form Russia

Jul 09, 2020 | Regulatory

43. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Clinical Trial

42. Angion Commences P-II Study of ANG-3777 in Patients with Acute Lung Injury Associated with COVID-19 Pneumonia in Brazil

Jul 08, 2020 | Clinical Trial

41. The European Commission Signs an Agreement with Roche and Merck to Supply their COVID-19 Therapies in EU

Jul 09, 2020 | Collaboration

40. GSK and Medicago to Initiate P-I Trial of Plant-Based COVID-19 Vaccine in July 2020

Jul 08, 2020 | Clinical Trial

39. Regeneron Signs an Agreement with BARDA and the US Department of Defense for REGN-COV2 Worth $450M

Jul 08, 2020 | Collaboration  

38. Innovation Pharmaceuticals Reports Results Brilacidin in COVID-19 Clinical Trial

 Jul 07, 2020 | Clinical Trial

37. Reven Reports Publication of Two COVID-19 Articles for RJX Platform

Jul 07, 2020 | Regulatory

36. Emergent Signs a Five-Year Manufacturing Services Agreement with Janssen for Ad26.COV2-S to Treat COVID-19  

Jul 07, 2020 | Collaboration   

35. Constant Therapeutics’ TXA127 will be Evaluated in P-II Trial for COVID-19 Patients

Jul 07, 2020 | Clinical Trial

34. Sinovac’s P-III COVID-19 Trial Receives the Brazilian Regulator Approval  

Jul 07, 2020 | Regulatory

33. Nasus Pharma Reports Results of TaffiX as a Intranasal Antiviral Protection Against SARS-CoV-2

Jul 07, 2020 | Clinical Trial

32. Mylan Receives EUA Approval for its Remdesivir to Treat COVID-19  

Jul 07, 2020 | Regulatory

31. Diffusion Pharmaceuticals Reports IND Submission for P-Ib/IIb COVID-19 Clinical Program with TSC to the US FDA

Jul 07, 2020 | Clinical Trial

30. Novavax to Receive $1.6B Funds from the US

Jul 07, 2020 | Grants

29. Aboundbio Signs an Agreement with SaudiVax for COVID-19

Jul 07, 2020 | Collaboration

28. Hepion Pharmaceuticals Reports Preclinical Results of CRV431 for Treating COVID-19

Jul 07, 2020 | Clinical Trial

27. Therapeutic Solution Reports Submission of Publication of Preclinical Data on StemVac for Supporting COVID-19 Indication

 Jul 07, 2020 | Clinical Trial

26. Regeneron with its Partner NIAID Report the Initiation of P-III Trial to Evaluate REGN-COV2 for Treatment and Prevention of COVID-19  

Jul 06, 2020 | Clinical Trial

25. Mylan’s Remdesivir Lyophilized Powder for Injection Receives the DCGI Accelerated Approval for Restricted Emergency Use in COVID-19 Patients in India    

Jul 06, 2020 | Regulatory

24. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

23. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Trial for Patients with COVID-19 in the US

Jul 03, 2020 | Clinical Trial

22. Moderna Reports the Enrollment of P-II Trial for its mRNA-1273 to Treat COVID-19  

Jul 03, 2020 | Clinical Trial

21. Sorrento Selects T-VIVA-19 as a Targeted Protein Vaccine Candidate Against COVID-19

Jul 02, 2020 | Clinical Trial

20. Dr. Reddy’s and GRA Collaborate with Fujifilm for Avigan (favipiravir) to Treat COVID-19 Outside Japan

Jul 02, 2020 | Collaboration

19. Pfizer and BioNTech Report Results of BNT162b1 mRNA-Based Vaccine in P-I/II Study Against COVID-19

Jul 02, 2020 | Clinical Trial

18. Zydus to Initiate Clinical Trials Evaluating ZyCoV-D Vaccine Against COVID-19 in July 2020

Jul 03, 2020 | Clinical Trial

17. Sanofi and Regeneron’s Kevzara (sarilumab) Fails in P-III Study for Patients with COVID-19 in the US

Jul 02, 2020 | Clinical Trial

16.  Phase II Study of MRx-4DP0004 in Patients Hospitalized with COVID-19 Open for Enrolment

Jul 02, 2020 | Clinical Trial

15.  Regulatory Authorities Step Up Cooperation in Connection with COVID-19

Jul 02, 2020 | Regulatory

14. Austria Donates €2M to CEPI to Support COVID-19 Vaccine Programmes

Jul 02, 2020 | Grant

13. Liminal BioSciences Joins CoVIg Plasma Alliance to Develop New COVID-19 Therapy

Jul 02, 2020 | Collaboration

12. Biophytis Receives FDA IND Clearance for COVA, a P-II/III Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Jul 02, 2020 | Clinical Trial

11.  EUSA Receives the US FDA Approval of P-III Clinical Trial for Siltuximab in Hospitalized Patients With COVID-19 Associated Acute Respiratory Distress Syndrome

Jul 02, 2020 | Clinical Trial

10.  Moderna Faces Delay in its COVID-19 Vaccine Trial

Jul 02, 2020 | Clinical Trial

9. Anivive Initiates Two Pre-Clinical Studies of GC376 for the Treatment of COVID-19

Jul 02, 2020 | Clinical Trial

8. MediciNova Announces Opening of IND for MN-166 (ibudilast) for Prevention of Acute Respiratory Distress Syndrome in Patients with COVID-19

Jul 01, 2020 | Clinical Trial

7. GoldenBiotech’s Antroquinonol Receives FDA Approval on COVID-19 P-II Trial in the US

Jul 01, 2020 | Regulatory

6. New Study Highlights Senhwa Biosciences Silmitasertib as Potential Treatment for COVID-19

Jul 01, 2020 | Clinical Trial

5. International Regulators Provide Guiding Principles for COVID-19 Clinical Trials

Jul 01, 2020 | Regulatory

4.  FibroGenesis Identifies Mechanism Responsible for Blocking COVID19-Like Lung Inflammation

Jul 01, 2020 | Clinical Trial

3. Inimmune Awarded $2M SBIR to Advance Vaccine Technologies

Jul 01, 2020 | Grant

2. UNION Receives Danish Medicines Agency’s Approval to Initiate Clinical Study With Niclosamide for Treatment of COVID-19

Jul 01, 2020 | Clinical Trial

1. FAMHP Facilitates and Supports the Development of COVID-19 Treatments and Vaccines

Jul 01, 2020 | Regulatory

Related Post : Insights+ Exclusive: COVID-19 Healthcare News Monthly Updates – June 2020




BARDA Signs a Multi-Year Agreement with Regeneron for its REGN-EB3 for National Preparedness

Shots:

  • Regeneron will be responsible to deliver treatment doses for six years post-approval of product from the FDA, will receive compensation of ~$10M & average of $67M/year in 2021 and each for the next five years (2022-2026) respectively
  • In 2019, the PALM trial evaluated REGN-EB3 vs ZMapp conducted in the Democratic Republic of the Congo, was stopped as the REGN-EB3 crossed the pre-specified superiority threshold for preventing death in Ebola patients
  • Regeneron’s REGN-EB3 is a novel anti-viral Ab cocktail developed using its VelociSuite platform in collaboration and funding provided by BARDA. The product is under priority review by the US FDA with PDUFA date Oct 25, 2020

Click here to read full press release/ article | Ref: BusinessWire | Image: Behnace